Drugs / Brexucabtagene Autoleucel
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell acute lymphoblastic leukemia 1 milestone | |||||
| Filed | US (FDA) | Tecartus | B-cell acute lymphoblastic leukemia | 2021-04-01 | “today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus ® (brexucabtagene autoleucel)” gilead.com ↗ “today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus® (brexucabtagene autoleucel)” gilead.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Tecartus | — | 2020-12-14 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03624036 | Nov 2018 → Feb 2021 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Kite, A Gilead Company | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02614066 | Mar 2016 → Jul 2022 | precursor B-cell acute lymphoblastic leukemia | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 1/2 | NCT02625480 | Feb 2016 → Mar 2026 | precursor B-cell acute lymphoblastic leukemia | Kite, A Gilead Company | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary | ||||||
| Phase 2 | NCT07673367 | Jul 2026 → Jul 2031 expected | mantle cell lymphoma | Vanderbilt-Ingram Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06253663 | Mar 2024 → Jul 2027 expected | mantle cell lymphoma, precursor B-cell acute lymphoblastic leukemia | Kite, A Gilead Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06482684 | Feb 2024 → Jun 2031 expected | mantle cell lymphoma | Christian Schmidt, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06144606 | Dec 2023 → Jul 2031 expected | B-cell acute lymphoblastic leukemia | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05537766 | Nov 2022 → Jan 2025 | Burkitt lymphoma, Richter transformation, Waldenstrom macroglobulinemia, hairy cell leukemia | Kite, A Gilead Company | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04880434 | Apr 2021 → Jun 2025 | mantle cell lymphoma | Kite, A Gilead Company | Completed | Met primary |
| Phase 2 | NCT03642626 | Dec 2018 → Feb 2024 overdue | acute lymphoblastic leukemia, large B-cell lymphoma | Masonic Cancer Center, University of Minnesota | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02601313 | Nov 2015 → Sep 2023 | mantle cell lymphoma | Kite, A Gilead Company | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT04162756 | — | mantle cell lymphoma | Kite, A Gilead Company | Approved for marketing | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT07763210 Background | Sep 2026 → Mar 2028 expected | diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06553872 Background | Aug 2024 → Aug 2029 expected | mantle cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| — | NCT05776134 Background | — | acute lymphoblastic leukemia, mantle cell lymphoma | Kite, A Gilead Company | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2024-12-09 | Kite, A Gilead Company | Results Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits kitepharma.com ↗
The data presented include an oral presentation (Abstract # 748) of a primary analysis of ZUMA-2 cohort 3 demonstrating an overall response rate (ORR) of 91% and complete response (CR) rate of 73% in Bruton tyrosine kinase inhibitor (BTKi)-naïve patients with R/R MCL. |
| 2024-12-09 | Gilead Sciences | Results Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits gilead.com ↗
With a median follow-up of 15.5 months (range, 1.4-27.1), the primary endpoint was met with an ORR of 91% (95% CI, 82.5-95.9; P<.0001). |
| 2024-11-05 | Kite, A Gilead Company | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World kitepharma.com ↗
Also to be presented are real-world outcomes in adults with R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) treated with Tecartus, highlighting the CAR T-cell therapy’s high effectiveness in a broader R/R B-ALL patient population. |
| 2024-11-05 | Gilead Sciences | Results Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024, Including Positive Survival Outcomes in Both Clinical Trials and the Real-World gilead.com ↗
Also to be presented are real-world outcomes in adults with R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) treated with Tecartus, highlighting the CAR T-cell therapy’s high effectiveness in a broader R/R B-ALL patient population. |
| 2024-06-03 | Kite, A Gilead Company | Results Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia kitepharma.com ↗
The findings showed a median OS of 25.6 months and a four-year OS rate of 40% (95% CI, 28-52) in all treated patients with a safety profile consistent with that observed in the three-year analysis. |
| 2024-06-03 | Gilead Sciences | Results Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia gilead.com ↗
The findings showed a median OS of 25.6 months and a four-year OS rate of 40% (95% CI, 28-52) in all treated patients with a safety profile consistent with that observed in the three-year analysis. |
| 2024-05-07 | Kite, A Gilead Company | Results Gilead and Kite Oncology to Highlight Broad and Diverse Oncology Portfolio at ASCO 2024 kitepharma.com ↗
These data continue to support the long-term survival and durability of Tecartus. |
| 2024-05-07 | Gilead Sciences | Results Gilead and Kite Oncology to Highlight Broad and Diverse Oncology Portfolio at ASCO 2024 gilead.com ↗
These data continue to support the long-term survival and durability of Tecartus. |
| 2023-12-11 | Kite, A Gilead Company | Results New Analyses Presented at ASH 2023 Support the Potential Long-Term Response and Safety of Kite’s Tecartus® in Patients With Aggressive Blood Cancers kitepharma.com ↗
The median OS for patients with complete response (CR) (n=46) was 58.7 months. |
| 2023-12-11 | Gilead Sciences | Results New Analyses Presented at ASH 2023 Support the Potential Long-Term Response and Safety of Kite’s Tecartus® in Patients With Aggressive Blood Cancers gilead.com ↗
The median OS for patients with complete response (CR) (n=46) was 58.7 months. |
| 2023-11-02 | Kite, A Gilead Company | Results Gilead and Kite Oncology Present Data Demonstrating CAR T-cell Therapy Survival Benefit and Showcasing Latest Advances in Blood Cancer Portfolio at ASH 2023 kitepharma.com ↗
The largest real-world evidence dataset for Tecartus (brexucabtagene autoleucel) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and relapsed/refractory mantle cell lymphoma (R/R MCL) will also be presented. |
| 2023-06-06 | Kite, A Gilead Company | Results Kite’s Tecartus® CAR T-cell Therapy Demonstrates 78% Complete Response Rate and 90% Overall Response Rate in Largest Real-World Evidence Analysis for Relapsed/Refractory Mantle Cell Lymphoma kitepharma.com ↗
Higher CR was seen when Tecartus was given as second-and-third-line compared to later lines of treatment. |
| 2023-06-06 | Gilead Sciences | Results Kite’s Tecartus® CAR T-cellTherapy Demonstrates 78% Complete Response Rate and 90% Overall Response Rate in Largest Real-World Evidence Analysis for Relapsed/Refractory Mantle Cell Lymphoma gilead.com ↗ |
| 2023-02-09 | Kite, A Gilead Company | Results Kite’s Tecartus® CAR T-Cell Therapy Demonstrates Overall Survival Benefit in Three-Year Follow-up of Pivotal ZUMA-3 Trial in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel). |
| 2023-02-09 | Gilead Sciences | Results Kite’s Tecartus® CAR T-Cell Therapy Demonstrates Overall Survival Benefit in Three-Year Follow-up of Pivotal ZUMA-3 Trial in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus ® (brexucabtagene autoleucel). |
| 2022-12-12 | Kite, A Gilead Company | Results New Analyses of Kite's Tecartus® CAR T-Cell Therapy Provide Additional Evidence Supporting Overall Survival and Durability of Response kitepharma.com ↗ |
| 2022-12-12 | Gilead Sciences | Results New Analyses of Kite's Tecartus® CAR T-Cell Therapy Provide Additional Evidence Supporting Overall Survival and Durability of Response gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced findings from follow-up analyses of two pivotal studies (ZUMA-2 and ZUMA-3) of the CAR T-cell therapy Tecartus ® (brexucabtagene autoleucel). |
| 2022-09-06 | Kite, A Gilead Company | Regulatory Kite’s CAR T-cell Therapy Tecartus® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) kitepharma.com ↗
“This approval makes Tecartus the first and only CAR T-cell therapy indicated for this population of patients, addressing a significant unmet medical need,” said Christi Shaw, CEO, Kite. |
| 2022-09-06 | Gilead Sciences | Regulatory Kite’s CAR T-cell Therapy Tecartus® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission (EC) has approved its CAR T-cell therapy Tecartus ® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2022-07-22 | Kite, A Gilead Company | Regulatory Kite’s CAR T-cell Therapy Tecartus® Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) kitepharma.com ↗ |
| 2022-07-22 | Gilead Sciences | Regulatory Kite’s CAR T-cell Therapy Tecartus® Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) gilead.com ↗
Today’s CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated. |
| 2022-06-04 | Kite, A Gilead Company | Results Tecartus® Car T-cell Therapy Demonstrates Strong Overall Survival Rates and Continued Durable Responses in Long-Term Follow-Up of Two Pivotal Studies Including Longest Ever Follow-Up of a CAR T-cell Therapy in Mantle Cell Lymphoma kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced longer-term follow-up results from two pivotal studies of the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel). |
| 2022-06-04 | Gilead Sciences | Results Tecartus® Car T-cell Therapy Demonstrates Strong Overall Survival Rates and Continued Durable Responses in Long-Term Follow-Up of Two Pivotal Studies Including Longest Ever Follow-Up of a CAR T-cell Therapy in Mantle Cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced longer-term follow-up results from two pivotal studies of the CAR T-cell therapy Tecartus ® (brexucabtagene autoleucel). |
| 2021-10-01 | Kite, A Gilead Company | Regulatory U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2021-10-01 | Gilead Sciences | Regulatory U.S. FDA Approves Kite’s Tecartus® as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus ® (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2021-06-04 | Kite, A Gilead Company | Results Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), announced today results from the primary analysis of ZUMA-3, a global, multicenter, single-arm, open-label Phase 1/2 study evaluating its chimeric antigen receptor (CAR) T-cell therapy Tecartus® (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2021-06-04 | Gilead Sciences | Results Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation gilead.com ↗
In this international, multicenter study, we observed a response rate of 71%. |
| 2021-04-01 | Kite, A Gilead Company | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2021-04-01 | Gilead Sciences | Regulatory Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus ® (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| 2020-12-16 | Kite, A Gilead Company | Regulatory Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). |
| 2020-12-16 | Gilead Sciences | Regulatory Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). |
| 2020-12-05 | Gilead Sciences | Results New Data for TecartusTM Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced follow-up results from the pivotal ZUMA-2 trial of Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19) in adult patients with relapsed or refractory mantle cell lymphoma (MCL). |
| 2020-10-16 | Kite, A Gilead Company | Regulatory European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗
The CHMP opinion recommends conditional authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. |
| 2020-10-16 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗
The CHMP opinion recommends conditional authorization, an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. |
| 2020-07-24 | Kite, A Gilead Company | Regulatory U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗ |
| 2020-07-24 | Gilead Sciences | Regulatory U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). |
| 2020-02-10 | Kite, A Gilead Company | Regulatory U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗
the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19 |
| 2020-02-10 | Gilead Sciences | Regulatory U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). |
| 2020-01-28 | Kite, A Gilead Company | Regulatory European Medicines Agency Validates Kite’s Marketing Application for Company’s Second CAR T Cell Therapy kitepharma.com ↗ |
| 2020-01-28 | Gilead Sciences | Regulatory European Medicines Agency Validates Kite’s Marketing Application for Company’s Second CAR T Cell Therapy gilead.com ↗ |
| 2019-12-11 | Kite, A Gilead Company | Regulatory Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy kitepharma.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). |
| 2019-12-11 | Gilead Sciences | Regulatory Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy gilead.com ↗ |
| 2019-12-09 | Kite, A Gilead Company | Results Kite Presents Positive Results From Pivotal ZUMA-2 Trial in Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗
After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. |
| 2019-12-09 | Gilead Sciences | Results Kite Presents Positive Results From Pivotal ZUMA-2 Trial in Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗
After a single infusion of KTE-X19, the best objective response via independent radiologic central review (n=60 evaluable for efficacy analysis) was 93 percent, with 67 percent of patients having achieved a complete response. |
| 2019-06-01 | Kite, A Gilead Company | Results Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗
today announced results from the completed Phase 1 of the ZUMA-3 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy. |
| 2019-06-01 | Gilead Sciences | Results Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗
Kite, a Gilead Company (Nasdaq: GILD), today announced results from the completed Phase 1 of the ZUMA-3 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy. |
| 2018-12-03 | Kite, A Gilead Company | Results Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗
With a median follow-up of 15.1 months (range 3.7 – 28.6 months) following a single infusion of KTE-X19, 69 percent of evaluable patients (n=25/36) achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi). |
| 2018-12-03 | Gilead Sciences | Results Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗
The rate of undetectable minimal residual disease (MRD) in patients who achieved complete tumor remission was 100 percent. |
All press releases naming this drug 49 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brexucabtagene Autoleucel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05776134 ↗ |
| Known as | brexu-cel | “ZUMA-8 evaluated the safety of brexucabtagene autoleucel (brexu-cel), a CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapy, for patients with...” PMID 40209059 ↗ Aug 20251“Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for adults with relapsed/refractory (R/R) mantle cell...” PMID 41160777 ↗ Mar 2026 |
| Known as | KTE-X19 | “Here we present the 3-year results of ZUMA-4, a phase I/II multicenter study evaluating the safety and efficacy of KTEX19, an autologous anti-CD19 chimeric antigen receptor...” PMID 36263840 ↗ Mar 20234“Brexucabtagene Autoleucel (KTE-X19)” NCT04162756 ↗ “Brexucabtagene Autoleucel (KTE-X19)” NCT02625480 ↗ |
| Known as | Tecartus | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03642626 ↗ |
| Modality | Cell therapy | “an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 42036693 ↗ Apr 2026 |
| Route | Intravenous | “A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.” NCT02614066 ↗ |
| Target | CD19 | “an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 36263840 ↗ Mar 2023 |