6 recruiting, 4 active not recruiting, 2 completed, 2 unknown. 10 Phase 2, 4 Phase 3, 2 Not applicable, 1 Phase 1.
Follow Axi-cel: new trials by email Literature Review of Axi-cel trials Research Report on Axi-cel
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 |
| Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells Axicabtagene Ciloleucel, Biospecimen Collection, Chemotherapy - Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | Phase 2 | Recruiting | City of Hope Medical Center | 56 | 2026-02-11 | 2026-03-05 |
| A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy rondecabtagene autoleucel, axicabtagene ciloleucel, lisocabtagene maraleucel - Large B-cell Lymphoma, Lymphoma, B-Cell | Phase 3 | Recruiting | Lyell Immunopharma, Inc. | 400 | 2026-01-12 | 2026-08-04 |
| Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma Axicabtagene Ciloleucel - CAR-T Cell Therapy, High-risk Large B-cell Lymphoma (LBCL) | Not applicable | Not yet recruiting | Ruijin Hospital | 60 | 2025-04-30 | 2025-04-22 |
| Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma Leukapheresis, Bridging Therapy, Lymphodepletion - B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent | Phase 2 | Terminated | Universität Münster | 1 | 2025-03-13 | 2025-09-04 |
| 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 | 2026-11-03 |
| Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL Comprehensive Ablative Bridging Irradiation (CABI), Chimeric Antigen Receptor T-Cell Therapy - Large B-cell Lymphoma, Relapsed Non-Hodgkin Lymphoma | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 27 | 2023-11-08 | 2026-03-31 |
| Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy Itacitinib, Chimeric antigen receptor (CAR) T-cell therapy - Diffuse Large B Cell Lymphoma | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 27 | 2023-05-19 | 2026-09-16 |
| Axi-cel Retreatment in Relapsed/Refractory LBCL axi-cel - CAR-T Retreatment | Not applicable | Unknown | Ruijin Hospital | 32 | 2023-03-04 | 2023-04-05 |
| Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine - High-risk Large B-cell Lymphoma (LBCL) | Phase 3 | Active not recruiting | Kite, A Gilead Company | 300 | 2023-02-10 | 2026-04-15 |
| Comparison of Point-of-care Produced CAR T-cell With Commercial CAR T-cells in Patients With R/R LBCL ARI-0001, Axi-cel - NHL, DLBCL - Diffuse Large B Cell Lymphoma | Phase 2 | Active not recruiting | University Medical Center Groningen | 340 | 2022-10-18 | 2026-10-05 |
| Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine - Relapsed/Refractory Follicular Lymphoma | Phase 3 | Active not recruiting | Kite, A Gilead Company | 231 | 2022-09-22 | 2025-10-15 |
| Chidamide Bridging for CAR-T Therapy Chidamide, Fludarabine and cyclophosphamide, Anti-CD19 CAR-T cells - Non Hodgkin's Lymphoma | Phase 1 / Phase 2 | Unknown | Chinese PLA General Hospital | 120 | 2022-05-25 | 2024-03-06 |
| Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation axicabtagene ciloleucel - B-Cell Lymphoma Refractory, B-cell Lymphoma Recurrent | Phase 2 | Active not recruiting | The Lymphoma Academic Research Organisation | 62 | 2021-03-10 | 2026-03-27 |
| Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide - Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Phase 3 | Completed | Kite, A Gilead Company | 359 | 2018-01-25 | 2025-12-01 |
| A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma Axicabtagene ciloleucel, Cyclophosphamide, Fludarabine - Follicular Lymphoma, Marginal Zone Lymphoma | Phase 2 | Completed | Kite, A Gilead Company | 159 | 2017-06-06 | 2025-12-23 |
Lymphoma, Large B-Cell, Diffuse (5) · Lymphoma, Non-Hodgkin (3) · Lymphoma, B-Cell (2) · Lymphoma, Follicular (2) · Dendritic Cell Sarcoma, Interdigitating (1) · Lymphoma (1) · Lymphoma, B-Cell, Marginal Zone (1) · Lymphoma, Mantle-Cell (1)
Kite, A Gilead Company (4) · H. Lee Moffitt Cancer Center and Research Institute (2) · Ruijin Hospital (2) · Chinese PLA General Hospital (1) · City of Hope Medical Center (1) · Lyell Immunopharma, Inc. (1) · M.D. Anderson Cancer Center (1) · The Lymphoma Academic Research Organisation (1) · University Medical Center Groningen (1) · University of Michigan Rogel Cancer Center (1) · Universität Münster (1)
United States (10) · France (5) · Germany (4) · China (3) · Italy (3) · Netherlands (3) · Spain (3) · United Kingdom (3) · Australia (2) · Austria (2) · Belgium (2) · Canada (2) · Japan (2) · Israel (1) · Portugal (1)
Michael Jain, MD, PhD (2) · Georg Lenz, Prof (1) · Jason Westin, MD (1) · Karamjeet S Sandhu (1) · Monalisa Ghosh (1) · Roch Houot, PhD (1) · Weidong Han, Ph.D (1)
PMID 33288485, PMID 34515338, PMID 34922648, PMID 35114155, PMID 37710005, PMID 38635762, PMID 39240498, PMID 40536814, PMID 41100801, PMID 41512176, PMID 42745632
2017 (2), 2023 (1), P30CA033572 (1)