Drugs / Brexucabtagene Autoleucel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Tecartus | — | 2020-12-14 | europa.eu ↗ |
Trials 12 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 → Nov 2028 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 |
| Phase 2 | NCT04880434 | Apr 2021 → Jun 2025 | mantle cell lymphoma | Kite, A Gilead Company | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04162756 | — | mantle cell lymphoma | Kite, A Gilead Company | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06553872 Background | Aug 2024 → Aug 2029 expected | mantle cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05776134 Background | — | acute lymphoblastic leukemia, mantle cell lymphoma | Kite, A Gilead Company | Available | No outcome recorded |
Press releases naming this drug 37 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-12-09 | Kite, A Gilead Company | Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits kitepharma.com ↗ |
| 2024-12-09 | Gilead Sciences | Longest Follow-Up Data Reported for Kite’s Tecartus® CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits gilead.com ↗ |
| 2024-06-03 | Kite, A Gilead Company | Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia kitepharma.com ↗ |
| 2024-06-03 | Gilead Sciences | Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia gilead.com ↗ |
| 2023-12-11 | Kite, A Gilead Company | 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 ↗ |
| 2023-12-11 | Gilead Sciences | 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 ↗ |
| 2023-06-06 | Kite, A Gilead Company | 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 ↗ |
| 2023-06-06 | Gilead Sciences | 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 | 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 ↗ |
| 2023-02-09 | Gilead Sciences | 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 ↗ |
| 2022-12-12 | Kite, A Gilead Company | 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 | New Analyses of Kite's Tecartus® CAR T-Cell Therapy Provide Additional Evidence Supporting Overall Survival and Durability of Response gilead.com ↗ |
| 2022-09-06 | Kite, A Gilead Company | 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 ↗ |
| 2022-09-06 | Gilead Sciences | 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 ↗ |
| 2022-07-22 | Kite, A Gilead Company | 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 | Kite’s CAR T-cell Therapy Tecartus® Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) gilead.com ↗ |
| 2022-06-04 | Kite, A Gilead Company | 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 ↗ |
| 2022-06-04 | Gilead Sciences | 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 ↗ |
| 2021-10-01 | Kite, A Gilead Company | 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 ↗ |
| 2021-10-01 | Gilead Sciences | 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 ↗ |
| 2021-06-04 | Kite, A Gilead Company | Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation kitepharma.com ↗ |
| 2021-06-04 | Gilead Sciences | Kite's Tecartus® Demonstrates High Response Rate in Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Earning Priority Review Designation gilead.com ↗ |
| 2021-04-01 | Kite, A Gilead Company | 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 ↗ |
| 2021-04-01 | Gilead Sciences | 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 ↗ |
| 2020-12-16 | Kite, A Gilead Company | Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe kitepharma.com ↗ |
| 2020-12-16 | Gilead Sciences | Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe gilead.com ↗ |
| 2020-12-05 | Kite, A Gilead Company | New Data for Tecartus™ Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗ |
| 2020-10-16 | Kite, A Gilead Company | European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗ |
| 2020-10-16 | Gilead Sciences | European CHMP Adopts Positive Opinion for Kite’s KTE-X19 for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗ |
| 2020-07-24 | Kite, A Gilead Company | 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 | U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗ |
| 2020-02-10 | Kite, A Gilead Company | U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma kitepharma.com ↗ |
| 2020-02-10 | Gilead Sciences | U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma gilead.com ↗ |
| 2019-06-01 | Kite, A Gilead Company | Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗ |
| 2019-06-01 | Gilead Sciences | Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗ |
| 2018-12-03 | Kite, A Gilead Company | Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia kitepharma.com ↗ |
| 2018-12-03 | Gilead Sciences | Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia gilead.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 18 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 | KTEX19 | “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 NCT06144606 ↗ |
| 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 |