LCAR-B38M

also known as cilta-cel · ciltacabtagene autoleucel

Developed for: plasma cell myeloma · refractory plasma cell neoplasm
Investigated by: Nanjing Legend Biotech Co. · Janssen Research & Development, LLC · Jiangsu Provincial People's Hospital · Ruijin Hospital · Second Affiliated Hospital of Xi'an Jiaotong University · Shanghai Changzheng Hospital

Trials 2

today NCT03758417 · Ph 2 NCT03090659 · Ph 1/2

201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 1/21 trial
Phase 1/2	NCT03090659	Oct 2015 → Dec 2023	refractory plasma cell neoplasm	Nanjing Legend Biotech Co.	Unknown	No outcome recorded
Phase 21 trial
Phase 2	NCT03758417	Jan 2019 → Jul 2025	plasma cell myeloma	Nanjing Legend Biotech Co.	Terminated	No outcome recorded Stop: Business

Press releases naming this drug 67 releases

Date	Issuer	Release
2026-09-25	Janssen Research & Development, LLC	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 ↗
2026-09-25	Janssen Research & Development, LLC	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 ↗
2025-06-03	Janssen Research & Development, LLC	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	Janssen Research & Development, LLC	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 ↗
2024-12-09	Janssen Research & Development, LLC	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	Janssen Research & Development, LLC	CARVYKTI® (ciltacabtagene autoleucel) demonstrated significantly higher rates of minimal residual disease (MRD) negativity compared to standard therapies in the CARTITUDE-4 study jnj.com ↗
2024-07-02	Janssen Research & Development, LLC	CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study jnj.com ↗
2024-07-02	Janssen Research & Development, LLC	CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study jnj.com ↗
2024-06-03	Janssen Research & Development, LLC	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	Janssen Research & Development, LLC	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 ↗
2024-04-22	Janssen Research & Development, LLC	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 ↗
2024-04-22	Janssen Research & Development, LLC	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 ↗
2024-04-22	Nanjing Legend Biotech Co.	CARVYKTI® (ciltacabtagene autoleucel) Approved by the European Commission for Second-line Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗
2024-04-05	Nanjing Legend Biotech Co.	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 ↗
2024-03-15	Janssen Research & Development, LLC	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 ↗
2024-03-15	Janssen Research & Development, LLC	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 ↗
2024-03-15	Nanjing Legend Biotech Co.	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 ↗
2024-02-23	Janssen Research & Development, LLC	Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma jnj.com ↗
2024-02-23	Janssen Research & Development, LLC	Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma jnj.com ↗
2024-02-23	Nanjing Legend Biotech Co.	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 ↗
2023-12-11	Janssen Research & Development, LLC	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	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	Nanjing Legend Biotech Co.	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 ↗
2023-06-06	Nanjing Legend Biotech Co.	Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) legendbiotech.com ↗
2023-06-05	Janssen Research & Development, LLC	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	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	Nanjing Legend Biotech Co.	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 ↗
2023-05-25	Nanjing Legend Biotech Co.	Legend Biotech Announces Submission to the European Medicines Agency for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel) legendbiotech.com ↗
2023-01-27	Janssen Research & Development, LLC	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 ↗
2023-01-27	Janssen Research & Development, LLC	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 ↗
2023-01-27	Nanjing Legend Biotech Co.	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.	Legend Biotech Announces Acceptance of Its New Drug Application for Ciltacabtagene Autoleucel (Cilta-Cel) in China legendbiotech.com ↗
2022-11-03	Nanjing Legend Biotech Co.	Legend Biotech Shares Updated Data from Comprehensive Cilta-Cel Clinical Development Program at ASH 2022 legendbiotech.com ↗
2022-09-27	Nanjing Legend Biotech Co.	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	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 ↗
2022-06-04	Janssen Research & Development, LLC	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 ↗
2022-06-04	Nanjing Legend Biotech Co.	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 ↗
2022-05-26	Janssen Research & Development, LLC	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	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.	CARVYKTI® (ciltacabtagene autoleucel) Granted Conditional Approval by the European Commission for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗
2022-03-25	Nanjing Legend Biotech Co.	CARVYKTI® (ciltacabtagene autoleucel) Receives Positive CHMP Opinion for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma legendbiotech.com ↗
2022-02-28	Janssen Research & Development, LLC	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 ↗
2022-02-28	Nanjing Legend Biotech Co.	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 ↗
2021-12-13	Nanjing Legend Biotech Co.	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 ↗
2021-12-12	Janssen Research & Development, LLC	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 ↗
2021-12-06	Nanjing Legend Biotech Co.	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 ↗
2021-11-04	Nanjing Legend Biotech Co.	Legend Biotech Showcases Updated and New Data from Comprehensive BCMA CAR-T, Cilta-Cel, Program and First Preclinical Results for Tri-specific CAR-T at 2021 ASH legendbiotech.com ↗
2021-11-01	Janssen Research & Development, LLC	Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel jnj.com ↗
2021-11-01	Janssen Research & Development, LLC	Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel jnj.com ↗
2021-11-01	Nanjing Legend Biotech Co.	Legend Biotech Announces Extension of PDUFA Date for Cilta-Cel legendbiotech.com ↗
2021-06-01	Janssen Research & Development, LLC	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 ↗
2021-06-01	Janssen Research & Development, LLC	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 ↗
2021-06-01	Nanjing Legend Biotech Co.	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 ↗
2021-05-26	Nanjing Legend Biotech Co.	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	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 ↗
2021-04-30	Nanjing Legend Biotech Co.	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 ↗
2021-02-01	Janssen Research & Development, LLC	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 ↗
2021-02-01	Nanjing Legend Biotech Co.	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	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	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	Nanjing Legend Biotech Co.	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	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 ↗
2020-12-05	Janssen Research & Development, LLC	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 ↗
2020-12-05	Nanjing Legend Biotech Co.	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 ↗
2020-11-05	Nanjing Legend Biotech Co.	Legend Biotech Announces ASH 2020 Data Presentations for Ciltacabtagene Autoleucel (cilta-cel), an Investigational BCMA CAR-T Cell Therapy in Development for Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM) legendbiotech.com ↗
2020-08-05	Nanjing Legend Biotech Co.	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 ↗
2018-12-03	Janssen Research & Development, LLC	Updated Data from Phase 1/2 Open-Label Study of BCMA-Directed CAR-T Cell Therapy LCAR-B38M Show Tolerable Safety Profile, High Overall Response and MRD Negative Rate in Treatment of Patients with Advanced Relapsed or Refractory Multiple Myeloma jnj.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

Field	Value	Cited text
Known as	LCAR-B38M	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03758417 ↗ 1 NCT03090659 ↗
Known as	cilta-cel	“PURPOSE: CARTIFAN-1 aimed to evaluate the efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-targeting chimeric antigen receptor T-cell...” PMID 36269898 ↗ Oct 2022
Known as	ciltacabtagene autoleucel	“The autologous anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy LCAR-B38M has been approved for the treatment of relapsed and refractory...” PMID 38659046 ↗ Apr 2024
Modality	Cell therapy	“LCAR-B38M is a chimeric antigen receptor T cell product with two binding domains targeting B cell maturation antigen.” PMID 35794616 ↗ Jul 2022
Route	Intravenous	“LCAR-B38M, at a median dose of 0.513 × 106 cells/kg, was intravenously administered either in three split infusions or in a single infusion.” PMID 35794616 ↗ Jul 2022