Drugs / Cilta-cel
Cilta-cel
English name ciltacabtagene autoleucel
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 4 milestones | |||||
| Filed | US (FDA) | CARVYKTI | plasma cell myeloma | 2023-06-06 | “submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for CARVYKTI®” jnj.com ↗ “Rolling submission of BLA to the FDA initiated for cilta-cel for the treatment of relapsed or refractory multiple myeloma (RRMM).” legendbiotech.com ↗ |
| Filed | EU (EMA) | CARVYKTI | plasma cell myeloma | 2023-05-25 | “a Type II Variation Application was submitted to the European Medicines Agency (EMA) by Janssen, seeking approval of CARVYKTI ®” legendbiotech.com ↗ “a Type II variation application was submitted to the European Medicines Agency (EMA) for CARVYKTI ®” legendbiotech.com ↗ |
| Filed | China (NMPA) | — | plasma cell myeloma | 2023-01-02 | “China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).” legendbiotech.com ↗ |
| Filed | EU (EMA) | — | plasma cell myeloma | 2021-04-30 | “On April 30, 2021 the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) was made by Legend Biotech’s collaborator, Janssen, for cilta-cel for the...” legendbiotech.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 3 milestones | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2020-12-21 | “announced today the initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ciltacabtagene autoleucel (cilta-cel)” legendbiotech.com ↗ “In May 2021 , the rolling submission of the Biologics License Application (BLA) was accepted by the U.S. FDA for cilta-cel” legendbiotech.com ↗ “A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA” legendbiotech.com ↗ |
| Filed | EU (EMA) | — | relapsed/refractory diffuse large B-cell lymphoma | — | “In May 2021 , the Marketing Authorisation Application (MAA) submitted by Janssen was accepted by the European Medicines Agency (EMA) for cilta-cel” legendbiotech.com ↗ “submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of cilta-cel” legendbiotech.com ↗ |
| Filed | Other | — | relapsed/refractory diffuse large B-cell lymphoma | — | “a submission for cilta-cel was made to the Brazilian Health Regulatory Agency by Janssen in April 2021.” legendbiotech.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Carvykti | — | 2022-05-25 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07093554 | Dec 2025 → Jul 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 1 | NCT06623630 | Dec 2024 → Jun 2027 expected | plasma cell myeloma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT05666700 | Dec 2023 → Jan 2026 overdue | plasma cell myeloma | Peter MacCallum Cancer Centre, Australia | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03548207 | Jun 2018 → Aug 2022 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT07149857 | Oct 2025 → Apr 2028 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06574126 | Sep 2024 → Sep 2032 expected | smoldering plasma cell myeloma | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06550895 | Sep 2024 → Aug 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05767359 | Apr 2023 → Dec 2025 overdue | smoldering plasma cell myeloma | Dana-Farber Cancer Institute | Active not recruiting | Met primary |
| Phase 2 | NCT05347485 | May 2022 → Nov 2023 | plasma cell myeloma | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04133636 | Nov 2019 → Feb 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05257083 | Oct 2023 → Jun 2033 expected | plasma cell myeloma | Stichting European Myeloma Network | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04923893 | Aug 2021 → Feb 2029 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04181827 | Jun 2020 → May 2024 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05201781 | Mar 2022 → Jul 2037 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05346835 | — | plasma cell myeloma | Janssen Scientific Affairs, LLC | Available | No outcome recorded |
| — | NCT04452994 | — | plasma cell myeloma | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06940297 Background | Jun 2025 → Aug 2031 expected | plasma cell myeloma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06577025 Background | Aug 2024 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 90
| Date | Issuer | Release |
|---|---|---|
| 2026-09-25 | Janssen Research & Development, LLC | Results Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma jnj.com ↗
Together, these findings add to the emerging evidence suggesting that CARVYKTI®may have curative potential in some patients. |
| 2026-09-25 | Janssen Research & Development, LLC | Results Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered five-year treatment-free remissions in 50% of patients in early line relapsed/refractory multiple myeloma jnj.com ↗
New results suggest earlier treatment may increase the likelihood of long-term remission |
| 2026-09-25 | Nanjing Legend Biotech Co. | Results Legend Biotech Presents CARVYKTI Data Showing Half of Patients with RRMM Remained Progression-Free and Alive Five Years After a Single Infusion legendbiotech.com ↗
The data showed that five years after a single CARVYKTI infusion, 10 of 20 patients (50%) remained alive and progression-free without maintenance therapy. |
| 2026-06-01 | Nanjing Legend Biotech Co. | Results Legend Biotech Presents First-in-Human LB2102 Results in Solid Tumors and New CARVYKTI® Data in Multiple Myeloma at ASCO 2026 legendbiotech.com ↗
Additionally, new analyses from the CARTITUDE program were presented, further highlighting sustained clinical benefit and a consistent safety profile for CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) in multiple myeloma. |
| 2026-01-21 | Nanjing Legend Biotech Co. | Results Legend Biotech to Present CARVYKTI® Data at 2026 Tandem Meetings Reinforcing Growing Evidence Supporting Earlier Use legendbiotech.com ↗
Quality-adjusted survival gains were clinically meaningful and driven by prolonged time without any multiple myeloma treatment, reinforcing the transformative potential of a single CARVYKTI ® infusion to deliver long-lasting benefit for patients with relapsed or refractory multiple myeloma. |
| 2025-12-06 | Janssen Research & Development, LLC | Results Earlier use of CARVYKTI® demonstrated lasting treatment-free remissions at 2.5 years in patients with relapsed or refractory multiple myeloma jnj.com ↗
Johnson & Johnson announced today updated results from the Phase 3 CARTITUDE-4 study supporting durable treatment-free remissions as early as second line treatment with CARVYKTI®(ciltacabtagene autoleucel; cilta-cel). |
| 2025-12-06 | Janssen Research & Development, LLC | Results Earlier use of CARVYKTI® demonstrated lasting treatment-free remissions at 2.5 years in patients with relapsed or refractory multiple myeloma jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today updated results from the Phase 3 CARTITUDE-4 study supporting durable treatment-free remissions as early as second line treatment with CARVYKTI (ciltacabtagene autoleucel; cilta-cel). |
| 2025-12-06 | Nanjing Legend Biotech Co. | Results Legend Biotech Highlights New CARVYKTI® Data in Multiple Myeloma and First-in-Human Results from Novel CAR-T Platform in Non-Hodgkin Lymphoma at ASH 2025 legendbiotech.com ↗
In triple-class-exposed patients who had received three prior lines of therapy, a median progression-free survival (mPFS) of 50.4 months was observed following a single infusion of CARVYKTI ® . |
| 2025-06-03 | Janssen Research & Development, LLC | Results Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma jnj.com ↗
In a heavily pre-treated population, a third of patients remained treatment- and progression-free for at least five years. |
| 2025-06-03 | Janssen Research & Development, LLC | Results Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma jnj.com ↗ |
| 2025-06-03 | Nanjing Legend Biotech Co. | Results Legend Biotech Unveils Groundbreaking 5-Year Survival Data for CARVYKTI® in Multiple Myeloma at 2025 ASCO Annual Meeting legendbiotech.com ↗
Notably, an unprecedented 33% (32 of 97) of patients remained progression-free for five years or more. |
| 2025-05-22 | Nanjing Legend Biotech Co. | Results Legend Biotech Announces New Oncologic & Hematologic Therapeutic Developments at ASCO, EHA, and ASGCT legendbiotech.com ↗
New data at ASCO from the CARTITUDE-4 study to showcase improved progression-free survival and overall survival with CARVYKTI ® versus standard of care (SOC) in key subgroups |
| 2024-12-09 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) demonstrated significantly higher rates of minimal residual disease (MRD) negativity compared to standard therapies in the CARTITUDE-4 study jnj.com ↗
Findings were featured in an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (Abstract #1032). |
| 2024-12-09 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) demonstrated significantly higher rates of minimal residual disease (MRD) negativity compared to standard therapies in the CARTITUDE-4 study jnj.com ↗ |
| 2024-12-09 | Nanjing Legend Biotech Co. | Results CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma legendbiotech.com ↗
These results reinforce the clinical value of CARVYKTI ® as early as second line and support the recent achievement of overall survival (OS) benefit versus standard therapies 1 . |
| 2024-11-05 | Nanjing Legend Biotech Co. | Results Legend Biotech to Unveil Minimal Residual Disease Data from Landmark CARTITUDE-4 Trial in Multiple Myeloma legendbiotech.com ↗
The significantly increased overall and sustained MRD negativity rates reinforce CARVYKTI as a transformative therapeutic option versus the standard of care for multiple myeloma patients as early as the second line. |
| 2024-09-27 | Janssen Research & Development, LLC | Results CARVYKTI® is the first and only cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line jnj.com ↗
These data show CARVYKTI®significantly extended OS for patients compared to standard therapies. |
| 2024-09-27 | Janssen Research & Development, LLC | Results CARVYKTI® is the first and only cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line jnj.com ↗ |
| 2024-09-27 | Nanjing Legend Biotech Co. | Results CARVYKTI® is the First and Only Cell Therapy to Significantly Extend Overall Survival Compared to Standard of Care in Patients with Multiple Myeloma as Early as Second Line legendbiotech.com ↗
At 30-months follow up, OS rates were 76 percent for patients in the CARVYKTI ® arm and 64 percent for patients treated with standard therapies. |
| 2024-08-09 | Nanjing Legend Biotech Co. | Results Legend Biotech Reports Second Quarter 2024 Results and Recent Highlights legendbiotech.com ↗
CARVYKTI ® demonstrates positive overall survival results in second interim analysis of CARTITUDE-4 study |
| 2024-07-02 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study jnj.com ↗
The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI®versus standard therapies. |
| 2024-07-02 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study jnj.com ↗ |
| 2024-07-02 | Nanjing Legend Biotech Co. | Results Legend Biotech Announces Positive Overall Survival Results of Landmark Phase 3 CARTITUDE-4 Trial in Multiple Myeloma legendbiotech.com ↗
In the pre-specified second interim analysis of the trial, CARVYKTI ® demonstrated statistically significant and clinically meaningful improvement in overall survival (OS). |
| 2024-06-03 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma jnj.com ↗
The data show CARVYKTI®(ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival (PFS) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for patients with lenalidomide-refractory multiple myeloma after one prior line of therapy (LOT), including patients with functional high-risk (FHR) multiple myeloma. |
| 2024-06-03 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma jnj.com ↗ |
| 2024-06-03 | Nanjing Legend Biotech Co. | Results Legend Biotech Shares Data on the Earliest Use to Date of CARVYKTI® in the Treatment of Multiple Myeloma and Important Subgroup Analyses at ASCO and EHA legendbiotech.com ↗
Results showed patients with less than a complete response (CR) after front-line autologous stem cell transplant (ASCT) experienced deep and durable responses following a single infusion of CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) with or without lenalidomide maintenance. |
| 2024-04-22 | Janssen Research & Development, LLC | Regulatory CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the European Commission (EC) has approved a Type II variation for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel). |
| 2024-04-22 | Janssen Research & Development, LLC | Regulatory CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, announced today that the European Commission (EC) has approved a Type II variation for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel). |
| 2024-04-22 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI® (ciltacabtagene autoleucel) Approved by the European Commission for Second-line Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2024-04-06 | Janssen Research & Development, LLC | Regulatory CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI®(ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. |
| 2024-04-05 | Janssen Research & Development, LLC | Regulatory CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. |
| 2024-04-05 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech’s CARVYKTI® (ciltacabtagene autoleucel) Becomes the First and Only BCMA-Targeted CAR-T Cell Therapy Approved by the FDA for Second-Line Treatment of Multiple Myeloma legendbiotech.com ↗
CARVYKTI ® is the first and only B-cell Maturation Antigen (BCMA) targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs), approved starting in the second-line of treatment for patients with multiple myeloma. |
| 2024-03-15 | Janssen Research & Development, LLC | Regulatory U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma jnj.com ↗
The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI®(11 to 0) finding the risk-benefit assessment of CARVYKTI®for the proposed indication as favorable. |
| 2024-03-15 | Janssen Research & Development, LLC | Regulatory U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma jnj.com ↗
The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. |
| 2024-03-15 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI® (ciltacabtagene autoleucel) Receives Recommendation from the U.S. FDA Oncologic Drugs Advisory Committee for Earlier Treatment of Patients with Relapsed/Refractory Multiple Myeloma legendbiotech.com ↗
The committee voted unanimously in favor of CARVYKTI (11 to 0) finding the risk-benefit assessment of cilta-cel for the proposed indication as favorable. |
| 2024-02-23 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for CARVYKTI®▼(ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM). |
| 2024-02-23 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma jnj.com ↗
Cilta-cel is the first chimeric antigen receptor T-cell (CAR-T) therapy to receive a positive CHMP opinion for the treatment of this patient population, as early as after first relapse. |
| 2024-02-23 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Positive CHMP Opinion for CARVYKTI® (ciltacabtagene autoleucel) for the Treatment of Patients with Relapsed and Lenalidomide Refractory Multiple Myeloma in Earlier Lines of Therapy legendbiotech.com ↗
CARVYKTI ® is the first CAR-T therapy for patients with relapsed and refractory multiple myeloma to receive a positive CHMP opinion for second line treatment |
| 2023-12-11 | Janssen Research & Development, LLC | Results Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma jnj.com ↗ |
| 2023-12-11 | Janssen Research & Development, LLC | Results Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma jnj.com ↗
CARVYKTI® exceeded clinically meaningful thresholds for average improvement in global health status (10.1 points), pain ( –10.2 points) and the visual analogue scale (8.0 points) from baseline to month 12; improvements in fatigue ( –9.1 points) and emotional functioning (9.5 points) neared clinically meaningful thresholds. |
| 2023-12-11 | Nanjing Legend Biotech Co. | Results Patient-Reported Outcomes from the CARTITUDE-4 Study Showed Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Multiple Myeloma Symptoms Following Treatment with CARVYKTI® (ciltacabtagene autoleucel) legendbiotech.com ↗
In CARTITUDE-4, CARVYKTI® demonstrated clinically meaningful improvements in patient-reported outcomes when compared to standard of care |
| 2023-06-06 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) |
| 2023-06-06 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2023-06-06 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) legendbiotech.com ↗
The sBLA seeks to expand the label for CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. |
| 2023-06-05 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study jnj.com ↗ |
| 2023-06-05 | Janssen Research & Development, LLC | Results CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study jnj.com ↗
CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study |
| 2023-06-05 | Nanjing Legend Biotech Co. | Results Ciltacabtagene Autoleucel (cilta-cel) Reduced Risk of Disease Progression or Death by 74% vs Standard Regimens for Adult Patients with Relapsed and Refractory Multiple Myeloma in CARTITUDE-4 Study legendbiotech.com ↗
Legend Biotech Corporation (NASDAQ: LEGN) ( Legend Biotech ), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that results from the Phase 3 CARTITUDE-4 study showed that, at a median follow up of 16 months, cilta-cel reduced the risk of disease progression or death by 74 percent compared to standard of care regimens in adult patients with multiple myeloma who have received one to three prior lines of therapy and are refractory to lenalidomide (Hazard ratio [HR]=0.26 (95% CI, 0.18–0.38); P-value [P] <0.0001). |
| 2023-05-25 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Submission to the European Medicines Agency for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) legendbiotech.com ↗
Legend Biotech Corporation (NASDAQ: LEGN) ( Legend Biotech ), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that a Type II variation application was submitted to the European Medicines Agency (EMA) for CARVYKTI ® based on data from the CARTITUDE-4 study ( NCT04181827 ), which investigates the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. |
| 2023-01-27 | Janssen Research & Development, LLC | Results Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗
As a result of meeting the primary endpoint, the Independent Data Monitoring Committee recommended the unblinding of the study. |
| 2023-01-27 | Janssen Research & Development, LLC | Results Janssen Announces Unblinding of Phase 3 CARTITUDE-4 Study of CARVYKTI® (cilta-cel) as Primary Endpoint Met in Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗
As a result of meeting the primary endpoint, the Independent Data Monitoring Committee recommended the unblinding of the study. |
| 2023-01-27 | Nanjing Legend Biotech Co. | Results Legend Biotech Announces Phase 3 CARTITUDE-4 Study of CARVYKTI® (ciltacabtagene autoleucel) Has Met Its Primary Endpoint in the Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2023-01-02 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Acceptance of Its New Drug Application for Ciltacabtagene Autoleucel (Cilta-Cel) in China legendbiotech.com ↗
Legend Biotech Corporation (NASDAQ: LEGN) ( Legend Biotech ), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). |
| 2022-09-27 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI™ (ciltacabtagene autoleucel) Receives Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2022-06-04 | Janssen Research & Development, LLC | Results Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy. |
| 2022-06-04 | Janssen Research & Development, LLC | Results Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
At nearly 28 months of median follow-up, median progression-free survival and overall survival were not yet reached |
| 2022-06-04 | Nanjing Legend Biotech Co. | Results Longer-Term Data from CARTITUDE Program Continue to Show Deep and Durable Responses with Ciltacabtagene Autoleucel Across Lines of Therapy in Patients with Multiple Myeloma legendbiotech.com ↗
Overall response rate remains at 98 percent after more than two years, with median progression-free and overall survival not yet being reached |
| 2022-05-26 | Janssen Research & Development, LLC | Regulatory European Commission Grants Conditional Approval of CARVYKTI® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗ |
| 2022-05-26 | Janssen Research & Development, LLC | Regulatory European Commission Grants Conditional Approval of CARVYKTI® (Ciltacabtagene Autoleucel), Janssen’s First Cell Therapy, for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗ |
| 2022-05-26 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI® (ciltacabtagene autoleucel) Granted Conditional Approval by the European Commission for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗
today announced that the European Commission (EC) has granted conditional marketing authorization of CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) |
| 2022-03-25 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI® (ciltacabtagene autoleucel) Receives Positive CHMP Opinion for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗
today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended Janssen Pharmaceutica NV’s marketing authorization of CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. |
| 2022-02-28 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. |
| 2022-02-28 | Nanjing Legend Biotech Co. | Regulatory CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma legendbiotech.com ↗
CARVYKTI™ marks the first product approved by a health authority for Legend Biotech |
| 2021-12-13 | Nanjing Legend Biotech Co. | Results Two-Year Analysis of CARTITUDE-1 Shows Early, Durable and Deepening Responses of Ciltacabtagene Autoleucel (cilta-cel) in Heavily Pretreated Patients with Multiple Myeloma legendbiotech.com ↗
After 21.7 months of follow-up, 83 percent of patients treated with cilta-cel achieved a stringent complete response (sCR)—higher than the 67 percent sCR rate reported at a median of ~1 year of follow up. |
| 2021-12-12 | Janssen Research & Development, LLC | Results New Data from CARTITUDE-1 Study Show Continued Deep and Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) in Treatment of Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Two-year PFS and OS rates were 61 percent (95 percent Confidence Interval [CI], 48.5–70.4) and 74 percent (95 percent CI, 61.9–82.7), respectively. |
| 2021-12-06 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Submission of New Drug Application to Japanese Regulatory Authority for BCMA CAR-T Therapy Cilta-cel for the Treatment of Relapsed or Refractory Multiple Myeloma by Janssen legendbiotech.com ↗ |
| 2021-11-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA). |
| 2021-11-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA). |
| 2021-11-01 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Extension of PDUFA Date for Cilta-Cel legendbiotech.com ↗
The FDA notified Janssen on October 28, 2021 of the extension of the PDUFA date to allow sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request. |
| 2021-06-01 | Janssen Research & Development, LLC | Results Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
These data also showed 66 percent of patients were progression free and alive at 18 months (95 percent Confidence Interval [CI], range, 54.9–75.0). |
| 2021-06-01 | Janssen Research & Development, LLC | Results Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). |
| 2021-06-01 | Nanjing Legend Biotech Co. | Results Legend Biotech Announces New and Updated Data for Investigational BCMA CAR-T Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed or Refractory Multiple Myeloma at 2021 ASCO and EHA Meetings legendbiotech.com ↗
The 18-month progression-free survival (PFS) rate was 66 percent (95 percent confidence interval [CI], 54.9-75.0) and overall survival rate (OS) rate was 81 percent (95 percent CI, 71.4-87.6). |
| 2021-05-26 | Nanjing Legend Biotech Co. | Regulatory U.S. Food and Drug Administration Grants BCMA CAR-T Cilta-cel Priority Review for the Treatment for Relapsed/Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2021-04-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. |
| 2021-04-30 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Submission of European Marketing Authorisation Application for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma legendbiotech.com ↗
The submission was filed to the EMA by Janssen-Cilag International N.V. , an affiliate of Janssen Biotech, Inc. , Legend’s collaboration partner for cilta-cel. |
| 2021-02-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-cel) Accepted for Accelerated Assessment in Europe for the Treatment of Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
Janssen Announces CAR-T Therapy Ciltacabtagene Autoleucel (Cilta-cel) Accepted for Accelerated Assessment in Europe for the Treatment of Patients with Heavily Pretreated Multiple Myeloma |
| 2021-02-01 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces BCMA CAR-T Therapy Cilta-cel Accepted for Accelerated Assessment in Europe for the Treatment of Relapsed and/or Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2020-12-21 | Janssen Research & Development, LLC | Regulatory Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma jnj.com ↗ |
| 2020-12-21 | Janssen Research & Development, LLC | Regulatory Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma jnj.com ↗
The FDA previously granted Breakthrough Therapy Designation (BTD) for cilta-cel and has agreed to a rolling review of the BLA in which completed portions of the application will be submitted and reviewed on an ongoing basis. |
| 2020-12-21 | Nanjing Legend Biotech Co. | Regulatory Legend Biotech Announces Initiation of Rolling Submission of Biologics License Application to U.S. FDA Seeking Approval of BCMA CAR-T Therapy Cilta-cel for the Treatment of Relapsed and/or Refractory Multiple Myeloma legendbiotech.com ↗ |
| 2020-12-05 | Janssen Research & Development, LLC | Results Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Median time to first response was one month (range, 0.9-8.5), with responses observed at a low dose of CAR-T cells (median administered dose 0.71 x 106CAR+ viable T cells/kg) and were ongoing in 72 percent (n=70) of patients. |
| 2020-12-05 | Janssen Research & Development, LLC | Results Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma |
| 2020-12-05 | Nanjing Legend Biotech Co. | Results Legend Biotech Announces Phase 1b/2 Study Data of Cilta-cel, an Investigational BCMA CAR-T, Showing Early, Deep, and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma legendbiotech.com ↗
The data continued to show a very high overall response rate (ORR) that deepened over time, with 97 percent of patients achieving a response and 67 percent of patients achieving a stringent complete response (sCR) at a median follow-up of 12.4 months. |
| 2020-08-05 | Nanjing Legend Biotech Co. | Regulatory The China Center for Drug Evaluation, National Medical Products Administration Has Recommended Breakthrough Therapy Designation for ciltacabtagene autoleucel (cilta-cel, LCAR-B38M CAR-T Cells), an Investigational BCMA CAR-T Cell Therapy legendbiotech.com ↗ |
| 2020-05-14 | Janssen Research & Development, LLC | Results Janssen’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The 100 percent overall response rate (ORR) included 97 percent of patients achieving a very good partial response or better and three percent achieving a partial response. |
| 2020-05-13 | Janssen Research & Development, LLC | Results Janssen’s BCMA CAR-T Therapy JNJ-4528 Showed Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Longer-term follow-up data from Phase 1b/2 CARTITUDE-1 study demonstrate 100% overall response rate, 86% stringent complete response rate at a median of 11.5 months and 86% progression-free survival at 9 months |
| 2020-05-13 | Nanjing Legend Biotech Co. | Results Updated Results from Phase 1b/2 Study of BCMA CAR-T Therapy JNJ-4528 Shows Early, Deep and Durable Responses in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma legendbiotech.com ↗
Longer-term follow up data (median of 11.5 months) from the Phase 1b portion of the CARTITUDE-1 study demonstrated 100% overall response rate, 86% stringent complete response rate and a 9 month progression free survival rate of 86%. |
| 2019-12-09 | Janssen Research & Development, LLC | Results Janssen Presents Initial Results for BCMA CAR-T Therapy JNJ-4528 Showing Early, Deep and High Responses in the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2019-12-09 | Janssen Research & Development, LLC | Regulatory Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously treated patients with multiple myeloma. |
| 2019-12-06 | Janssen Research & Development, LLC | Regulatory Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗
Janssen Announces BCMA CAR-T Therapy JNJ-4528 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma |
| 2019-04-15 | Janssen Research & Development, LLC | Regulatory Janssen Announces Investigational CAR-T Therapy JNJ-68284528 Granted PRIME Designation by the European Medicines Agency jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency (EMA) has granted a PRIME (PRIority MEdicines) designation for the company’s investigational B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, JNJ-68284528 (JNJ-4528). |
All press releases naming this drug 94 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cilta-cel | “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗12“Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory...” PMID 37272512 ↗ Jun 2023 “CARTITUDE-1 evaluated ciltacabtagene autoleucel (cilta-cel) in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM).” PMID 40459151 ↗ Jun 2025 “Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.” NCT05346835 ↗ |
| Known as | ciltacabtagene autoleucel | “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗8“JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is...” NCT05257083 ↗ “Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory...” PMID 37272512 ↗ Jun 2023 “CARTITUDE-1 evaluated ciltacabtagene autoleucel (cilta-cel) in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM).” PMID 40459151 ↗ Jun 2025 “Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.” NCT05346835 ↗ |
| Known as | Ciltacabtagene autoleucel (cilta-cel) | “Ciltacabtagene autoleucel (cilta-cel)” NCT04133636 ↗ |
| Known as | Ciltacabtagene autoleucel, JNJ-68284528 | “Ciltacabtagene autoleucel, JNJ-68284528” NCT06550895 ↗ |
| Known as | JNJ-68284528 | “JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule...” NCT06574126 ↗4“Combination Product: JNJ-68284528 (Cilta-cel) & 64Cu SPION dual PET-MR imaging agent” NCT05666700 ↗ |
| Modality | Cell therapy | “ciltacabtagene autoleucel (cilta-cel), a novel chimeric antigen receptor T (CAR-T) cell therapy” PMID 36357295 ↗ Oct 2022 |
| Route | Intravenous | “after single intravenous infusion administration of ciltacabtagene autoleucel” PMID 36204820 ↗ Oct 2022 |