7 recruiting, 4 completed, 3 active not recruiting, 2 terminated. 14 Phase 2, 3 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Recruiting 7, Completed 4, Active not recruiting 2, Terminated 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Early Phase 1 | 1 | Active not recruiting 1 |
Follow brexucabtagene autoleucel: new trials by email Literature Review of brexucabtagene autoleucel trials Research Report on brexucabtagene autoleucel
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy Axicabtagene Ciloleucel, Biospecimen Collection, Brexucabtagene Autoleucel - Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma | Phase 2 | Recruiting | University of Michigan Rogel Cancer Center | 26 | 2026-11-01 | 2026-10-23 |
| Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma Therapeutic Hydrocortisone, Cytarabine, Dexamethasone - Non-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma | Phase 2 | Recruiting | Vanderbilt-Ingram Cancer Center | 59 | 2026-09-25 | 2026-10-02 |
| Nemtabrutinib With CAR T Therapy in Relapsed/Refractory Mantle Cell Lymphoma Nemtabrutinib, Brexucabtagene autoleucel ( other names: brexu-cel , Tecartus) - Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma | Phase 2 | Recruiting | Vanderbilt-Ingram Cancer Center | 25 | 2026-07-31 | 2026-08-17 |
| Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL Pirtobrutinib, Brexucabtagene Autoleucel - Mantle Cell Lymphoma | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 60 | 2024-08-23 | 2026-09-23 |
| A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma Glofitamab, Obinutuzumab, Axi-cel - B Cell Lymphoma | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 40 | 2024-05-07 | 2026-09-24 |
| Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia KTE-X19, Cyclophosphamide, Fludarabine - Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia | Phase 2 | Active not recruiting | Kite, A Gilead Company | 25 | 2024-03-18 | 2026-06-25 |
| CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma KTE-X19, Ibrutinib - Mantle Cell Lymphoma | Phase 2 | Recruiting | Christian Schmidt, MD | 150 | 2024-02-15 | 2024-07-01 |
| Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL) Tecartus - B-Cell Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 60 | 2023-12-26 | 2026-09-25 |
| A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma Acalabrutinib, Rituximab, Brexucabtagene Autoleucel - Lymphoma, Mantle Cell Lymphoma | Early Phase 1 | Active not recruiting | M.D. Anderson Cancer Center | 22 | 2022-11-18 | 2026-08-12 |
| Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies Brexucabtagene Autoleucel, Cyclophosphamide, Fludarabine - Relapsed/Refractory Waldenstrom Macroglobulinemia, Relapsed/Refractory Richter Transformation | Phase 2 | Terminated | Kite, A Gilead Company | 19 | 2022-11-01 | 2026-03-10 |
| Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies Axicabtagene Ciloleucel, Brexucabtagene Autoleucel, Anitocabtagene autleucel - Solid and Hematological Malignancies, Autoimmune Diseases | Enrolling by invitation | Kite, A Gilead Company | 1500 | 2021-12-15 | 2026-09-21 | |
| Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel - Relapsed/Refractory Mantle Cell Lymphoma | Phase 2 | Completed | Kite, A Gilead Company | 95 | 2021-04-23 | 2026-08-18 |
| MT2017-45: CAR-T Cell Therapy for Heme Malignancies KYMRIAH, YESCARTA, Fludarabine 30mg/m2 4 doses - Acute Lymphoblastic Leukemia, Large B-cell Lymphoma | Phase 2 | Active not recruiting | Masonic Cancer Center, University of Minnesota | 150 | 2018-12-18 | 2026-01-23 |
| Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma brexucabtagene autoleucel, Fludarabine, Cyclophosphamide - Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma | Phase 1 | Terminated | Kite, A Gilead Company | 16 | 2018-11-15 | 2023-11-18 |
| A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) brexucabtagene autoleucel, Cyclophosphamide, Fludarabine - Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia | Phase 1 / Phase 2 | Completed | Kite, A Gilead Company | 125 | 2016-03-07 | 2024-11-19 |
| Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide - Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma | Phase 1 / Phase 2 | Completed | Kite, A Gilead Company | 95 | 2016-02-01 | 2026-04-09 |
| Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) brexucabtagene autoleucel, Cyclophosphamide, Fludarabine - Relapsed/Refractory Mantle Cell Lymphoma | Phase 2 | Completed | Kite, A Gilead Company | 105 | 2015-11-09 | 2026-03-18 |
| Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide - Relapse/Refractory Mantle Cell Lymphoma | Approved for marketing | Kite, A Gilead Company | 2021-10-14 | |||
| Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel Brexucabtagene Autoleucel - Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia | Available | Kite, A Gilead Company | 2026-04-08 |
Lymphoma, Mantle-Cell (11) · Recurrence (7) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (3) · Burkitt Lymphoma (2) · Lymphoma, B-Cell (2) · Lymphoma, Large B-Cell, Diffuse (2) · Autoimmune Diseases (1) · Hematologic Neoplasms (1) · Leukemia, Hairy Cell (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Lymphoma (1) · Lymphoma, B-Cell, Marginal Zone (1) · Lymphoma, Non-Hodgkin (1) · Waldenstrom Macroglobulinemia (1)
Kite, A Gilead Company (10) · H. Lee Moffitt Cancer Center and Research Institute (2) · M.D. Anderson Cancer Center (2) · Vanderbilt-Ingram Cancer Center (2) · Christian Schmidt, MD (1) · Masonic Cancer Center, University of Minnesota (1) · University of Michigan Rogel Cancer Center (1)
United States (17) · Germany (7) · France (6) · Netherlands (6) · Italy (4) · Spain (4) · Canada (3) · Austria (2) · Belgium (2) · Japan (2) · Switzerland (2) · United Kingdom (2) · Australia (1) · Czechia (1) · Israel (1)
Bhagirathbhai Dholaria (2) · Bijal D. Shah, MD (1) · Georg Hess, MD (1) · Jason Westin, MD (1) · Michael Jain, MD, PhD (1) · Monalisa Ghosh (1) · Preetesh Jain, MD, PHD (1) · Veronika Bachanova, MD, PhD (1)
PMID 42036693, PMID 32242358, PMID 33067318, PMID 33827116, PMID 34097852, PMID 35658525, PMID 35727476, PMID 36263840, PMID 36494725, PMID 40209059, PMID 40517546, PMID 41160777, PMID 41686452
2023 (4), 2015 (3), 2018 (1)