Table 8.
Selected trials of BCMA-directed CAR T-cell products in multiple myeloma (MM).
| Trial ID (References) | Drugs | Phase | Enrollment (N) | Trial Title |
|---|---|---|---|---|
| NCT03361748 [167] | Ide | II | 149 | Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects with RRMM (KarMMa) |
| NCT03601078 [180,181] | Ide +/− Len | II | 235 | Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects with RRMM and in Subjects with Clinical High-Risk MM (KarMMa-2) |
| NCT03651128 [168] | Ide + SOC MM agents | III | 381 | Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects with RRMM (KarMMa-3) |
| NCT04855136 | Ide + CC-220 vs. Ide + BMS-986405 | I/II | 312 | Exploratory Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects with RRMM (KarMMa-7) |
| NCT03548207 [182,183,184] | Cil | I/II | 126 | Open-Label Study of JNJ-68284528, A Chimeric Antigen Receptor T-Cell (CAR-T) Therapy Directed Against BCMA in Subjects with RRMM (CARTITUDE-1) |
| NCT04133636 [185,186,187] | Cil + Len + Dara + Dex + Bort | II | 169 | Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects with MM (CARTITUDE-2) |
| NCT04181827 [171] | Pom + Bort + Dex + Dara +/− Cil | III | 419 | 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 MM (CARTITUDE-4) |
| NCT04923893 [188] | Bort + Dex + Len + Cil + Ctx + Flu | III | 650 | Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with NDMM for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (CARTITUDE-5) |
| NCT05257083 [189] | Dara + Bort + Len + Dex +/− (Cil + Ctx + Flu) | III | 750 | Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by ASCT in Participants with NDMM Who Are Transplant Eligible (CARTITUDE-6) |
| NCT03758417 [190] | Cil | II | 130 | Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects with RRMM (CARTIFAN-1) |
| NCT03090659 [191] | Cil | I/II | 100 | Study of Legend Biotech BCMA-chimeric Antigen Receptor Technology in Treating RRMM Patients (LEGEND-2) |
| NCT03975907 [173] | Zev | I/II | 114 | Open Label Trial to Evaluate the Safety and Efficacy of Fully Human Anti-BCMA Chimeric Antibody Receptor Autologous T Cell (CAR T) in Patients with RRMM (LUMMICAR STUDY 1) |
| NCT03915184 [192,193] | Zev | I/II | 105 | Open Label, Multi-center Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients with RRMM (LUMMICAR STUDY 2) |
| NCT05066646 [172] | CT103A | I/II | 132 | Study on Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (CT103A) in the Treatment of Patients with RRMM (FUMANBA-1) |
| NCT04318327 [194] | PHE885 | I | 96 | Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients with MM |
| NCT05172596 | PHE885 | II | 136 | Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants with RRMM. |
| NCT05521802 | C-CAR088 | I/II | 92 | Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients with RRMM |
| NCT04295018 [176] | C-CAR088 | I | 10 | A Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects with RRMM |
| NCT05396885 [195] | CART-ddBCMA | II | 110 | Study of CART-ddBCMA for the Treatment of Patients with RRMM (IMMagine-1) |
| NCT04394650 [196] | CC-98633/BMS-986354 | I | 150 | Multi Center, Open Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects with RRMM |
| NCT04720313 [178] | NXC-201 | I | 160 | Dose Escalation and Safety Study of NXC-201 (Formerly HBI0101) CART in BCMA-Expressing MM Patients and AL Amyloidosis |
AL = amyloid light chain; Bort = bortezomib; Cil = ciltacabtagene autoleucel; Ctx = cyclophosphamide; Dara = daratumumab; Dex = dexamethasone; Flu = fludarabine; Ide = idecabtagene vicleucel; Len = lenalidomide; MM = multiple myeloma; NDMM = newly diagnosed multiple myeloma; Pom = pomalidomide; RRMM = relapsed and/or refractory multiple myeloma; SOC = standard of care; Zev = zevorcabtagene autoleucel.