Table 3.
Active trials of BCMA-targeted chimeric antigen receptor T-Cells in RRMM.
| Trial ID [References] | Treatment | Phase | Enrollment | Trial Title |
|---|---|---|---|---|
| NCT02215967 [129] | Anti-BCMA-CAR T cells + Ctx + Flu | I | 30 | A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma |
| NCT03502577 [34] | Anti-BCMA-CAR T cells + Ctx + Flu + LY3039478 (gamma-secretase inhibitor) | I | 18 | A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma |
| NCT02658929 [130] | bb2121 | I | 67 | A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma (CRB-401) |
| NCT03361748 [131] | Idecabtagene vicleucel (bb2121) | II | 149 | A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma (KarMMa-1) |
| NCT03601078 [132] | Idecabtagene vicleucel (bb2121) | II | 181 | A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects with Clinical High-Risk Multiple Myeloma (KarMMa-2) |
| NCT03651128 | Idecabtagene vicleucel (bb2121) + standard MM regimens | III | 381 | A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3) |
| NCT04196491 | Idecabtagene vicleucel (bb2121) + Carf + Ctx + Flu + Len | I | 60 | A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects with High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4) |
| NCT02786511 | Idecabtagene vicleucel (bb2121) | -- | 50 | Longterm Follow-up of Subjects Treated With bb2121 |
| NCT03274219 [133] | bb21217 | I | 74 | A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and/or Refractory Multiple Myelom |
| NCT03090659 [134,135,136] | JNJ-68284528 (LCAR-B38M) | I/II | 100 | A Clinical Study of Legend Biotech BCMA-chimeric Antigen Receptor Technology in Treating Relapsed/Refractory (R/R) Multiple Myeloma Patients (LEGEND-2) |
| NCT03548207 [137] | JNJ-68284528 (LCAR-B38M) | I/II | 118 | A Phase 1b-2, Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects with Relapsed or Refractory Multiple Myeloma (CARTITUDE-1) |
| NCT04133636 | JNJ-68284528 (LCAR-B38M) + Len | II | 80 | A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma (CARTITUDE-2) |
| NCT04181827 | JNJ-68284528 (LCAR-B38M) + Pom + Bort + Dex + Dara | III | 400 | A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4) |
| NCT03288493 [138] | P-BCMA-101 + Rimiducid | I/II | 220 | Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects with Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME) |
| NCT03741127 [139] | P-BCMA-101 + Rimiducid | I | 100 | Open Label, Multicenter, Long-Term Follow-Up Study for Subjects Treated With P-BCMA-101 |
| NCT03070327 [55,140] | MCARH171 + Ctx + Len | I | 20 | A Phase I Trial of B-cell Maturation Antigen (BCMA) Targeted EGFRt/BCMA-41BBz Chimeric Antigen Receptor (CAR) Modified T Cells With or Without Lenalidomide for the Treatment of Multiple Myeloma (MM) |
| NCT03338972 [55,141] | FCARH143 + Ctx + Flu | I | 25 | A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor |
| NCT03430011 [55,142] | JCARH125 | I/II | 245 | An Open-Label Phase 1/2 Study of JCARH125, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory Multiple Myeloma |
| NCT03975907 [143] | CT053 | I/II | 62 | An Open Label, Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-BCMA Chimeric Antibody Receptor Autologous T Cell (CAR T Infusion in Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT03915184 [143] | CT053 | I | 70 | Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT04155749 | CART-ddBCMA | I | 12 | Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up |
| NCT03448978 [144] | Descartes-08 + Ctx + Flu | I/II | 30 | Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma |
| NCT02546167 [145,146,147] | CART-BCMA | I | 25 | Pilot Study Of Redirected Autologous T Cells Engineered To Contain an Anti-BCMA scFv Coupled To TCRζ And 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT03455972 [148] | CART-anti-CD19/BCMA | I/II | 15 | Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT |
| NCT03196414 [149] | CART-anti-CD19/BCMA | I/II | 10 | Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma |
| NCT03549442 [150] | BCMA CART + huCART19 | I | 39 | Phase 1 Study of CART-BCMA With or Without huCART19 as Consolidation of Standard First or Second-Line Therapy for High-Risk Multiple Myeloma |
| NCT03706547 [150] | Anti-CD19/BCMA CAR-T cells | I | 20 | Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma |
| NCT03767725 [150] | Anti-BCMA or/and Anti-CD19 CAR Autologous T Cells | I | 10 | Phase I Trial Study of Anti-BCMA (B-cell Maturation Antigen) or/and Anti-CD19 Chimeric Antigen Receptor T Cells (CART Cell) Treatment for the Patient of Relapsed Multiple Myeloma |
| NCT03602612 [151] | Anti-BCMA CAR T cells + Ctx + Flu | I | 42 | A Phase I Clinical Trial of T Cells Expressing a Novel Fully-human Anti-BCMA CAR for Treating Multiple Myeloma |
| NCT04093596 [152,153,154] | ALLO-715 + ALLO-647 + Ctx + Flu |
I | 90 | A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/ Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma (UNIVERSAL) |
| NCT04171843 [155] | PBCAR269A + Ctx + Flu | I/II | 48 | A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A in Study Participants With Relapsed/Refractory Multiple Myeloma |
Abbreviations: Bort = bortezomib; Carf = carfilzomib; Ctx = cyclophosphamide; Dara = daratumumab; Dex = dexamethasone; Flu = fludarabine; Len = lenalidomide; Pom = pomalidomide.