Table 2.
CAR-T cell therapies, ADC, and BiTE.
| Study Title | Target | Recruited (Evaluable) | Efficacy Data | CRS Grade 3–4 [Neurotoxicity] | Trial Registration | Reference |
|---|---|---|---|---|---|---|
| bb2121 anti-BCMA CAR T-Cell Therapy in Patients with Relapsed/refractory Multiple Myeloma: Updated Results from a Multicenter Phase I Study | BCMA | N = 33 | ORR: 85%, CR: 45%, mPFS: 11.8 mo | 5% [2%] | NCT02658929 | [156] |
| Safety and Efficacy of B-cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells (CART-BCMA) with Cyclophosphamide Conditioning for Refractory Multiple Myeloma (MM) | BCMA | N = 25 | ORR: 64% for the highest dose | 32% [12%] | NCT02546167 | [157] |
| Updated Analysis of a Phase 1, Open-Label Study of LCAR-B38M, a Chimeric Antigen Receptor T Cell Therapy Directed Against B-Cell Maturation Antigen, in Patients with Relapsed/Refractory Multiple Myeloma | BCMA | N = 57 | ORR: 88%, CR: 68%, mPFS: 15 mo at median 8mo f/u | 7% [0%] | NCT03090659 | [158] |
| Initial Results from a Phase 1 Clinical Study of bb21217, a Next-Generation Anti BCMA CAR T Therapy | BCMA | N = 7 | ORR: 86%, CR: 25% | 14% [14%] | NCT03274219 | [159] |
| Fully Human BCMA Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma | BCMA | N = 7 | ORR: 100% | 0% [0%] | NCT03338972 | [160] |
| Efficacy and Safety of P-Bcma-101 CAR-T Cells in Patients with Relapsed/Refractory (r/r) Multiple Myeloma (MM) | BCMA | N = 23 | ORR: 81% | 0% [4.8%] | NCT03288493 | [161] |
| Clinical Reponses and Pharmacokinetics of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma | BCMA | N = 9 | ORR: 100%, CR: 67% | 0.2% [0%] | ChiCTR1800018137 | [162] |
| Improved Efficacy and Safety of a Dual-Target CAR-T Cell Therapy Targeting BCMA and CD38 for Relapsed/refractory Multiple Myeloma | BCMA and CD38 | N = 12 | ORR: 83.3%, ≥VGPR: 58.3% | 33.3% [0%] | ChiCTR1800018143 | [163] |
| Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived Bcma Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial | BCMA | N = 11 | ORR: 100% | 20% [0%] | NCT03070327 | [164] |
| Durable Remission Achieved from BCMA-Directed CAR-T Therapy Against Relapsed or Refractory Multiple Myeloma | BCMA | N = 17 | ORR: 79% | 7% [7%] | NCT03093168 | [165] |
| JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE) | BCMA | N = 19 | ORR: 100%, CR: 67% | 0% [12.5%] | NCT03430011 | [166] |
| T Cells Genetically Modified to Express an Anti-B cell Maturation Antigen Chimeric Antigen Receptor Cause Remissions of Poor-Prognosis Relapsed Multiple Myeloma | BCMA | N = 24 | ORR: 81% | 38% [19%] | NCT02215967 | [151] |
| Combined Infusion of CD19 and Bcma-Specific Chimeric Antigen Receptor T cells for RRMM: Initial Safety and Efficacy Report from a Clinical Pilot Study | BCMA/CD19 | N = 8 | ORR: 80% | 12.5% [0%] | NCT03196414 | [167] |
| Tandem Autologous Transplantation and Combined Infusion of CD19 and Bcma-Specific Chimeric Antigen Receptor T Cells for High Risk MM: Initial Safety and Efficacy Report from a Clinical Pilot Study | CD19/BCMA | N = 9 | ORR: 100%, CR: 51% | 0% [0%] | NCT03455972 | [168] |
| Low Dose of Human scFv-Derived BCMA-Targeted CAR-T Cells Achieved Fast Response and High Complete Remission in Patients with Relapsed/Refractory Multiple Myeloma. Jiang S et al. Blood 2018 132 960 | BCMA | N = 16 | ORR: 100% | 6% [0%] | NA | [169] |
| T Cells Expressing Anti B-cell Maturation Antigen Receptors for Plasma Cell Malignancies | BCMA | N = 28 | ORR: 87% | 14% [0%] | NA | [170] |
| B-Cell Maturation Antigen Antibody-Drug Conjugate (ADC), GSK2857916, in Relapsed/refractory Multiple Myeloma (RRMM): Final Safety, Efficacy and Pharmacokinetic (PK) Analyses from a Phase I Study | BCMA | N = 73 | ORR: 60%, mPFS 12 mo | 20% [NA] | NA | [171] |
| Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CTL019) in Conjunction with Salvage Autologous Stem Cell Transplantation for Advanced Multiple Myeloma | CD19 | N = 10 | ORR: 20% | 0% [0%] | NCT2135406 | [172] |
| CD138-directed Adoptive Immunotherapy of Chimeric Antigen Receptor (CAR)-Modified T Cells for Multiple Myeloma | CD138 | N = 5 | -ORR: 80% | 0% [0%] | NCT01886976 | [173] |
| Clinical Responses with T lymphocytes Targeting Malignancy-associated κ Light Chains | Kappa LC | N = 7 | ORR: 0% | 0% [0%] | NCT00881920 | [145] |
| Safety and Efficacy of Multiantigen-Targeted T Cells for Multiple Myeloma | PRAME, SSX2, MAGEA4, NY-ESO-1 and Survivin | N = 18 (10) | CR: 10% | NA | NA | [174] |
| Evaluation of AMG 420, An Anti-BCMA Bispecific T-Cell Engager (BITE®) Immunotherapy, In R/R Multiple Myeloma (MM) Patients. Updated Results of a First-In-Human (FIH) Phase 1 Dose Escalation Study | BCMA BITE | N = 42 | ORR: 70%, ≥VGPR: 14.2% | Grade 2–3 CRS 7.1% | NCT02514239 | [163] |