Table 1 Summary of important clinical trials of CAR-T cells in multiple myeloma.
From: Targeted immunotherapy: harnessing the immune system to battle multiple myeloma
Agents | Study details | Patients | Regimens | Outcomes | Adverse events | Refs |
|---|---|---|---|---|---|---|
anti-BCMA CAR-T cells | NCT02215967 Phase I | R/RMM at least 3 prior lines n = 24 | LD chemotherapy followed by 0.3–9 × 106 CAR-T cells/kg | ORR: 81% at 9 × 106 CAR-T cells/kg; median EFS: 31 weeks | Any-grade CRS 94%, ≥grade 3 CRS 38%; ≥grade 3 NTX 19% at 9 × 106 CAR-T cells/kg | |
LCAR-B38M NCT03090659 Phase I | R/RMM at least 1 prior lines n = 57 | LD chemotherapy followed by 0.07–2.1 × 106 cells/kg CAR-T cells | ORR: 88%; median PFS 15 months | Any-grade CRS 90%, ≥grade 3 CRS 7%; any-grade NTX 1.7% (grade 1) | [15] | |
CT103A ChiCTR1800018137 Phase I | R/RMM at least 3 prior lines n = 18 | LD chemotherapy followed by 1–6 × 106 CAR-T cells/kg | ORR: 100%; 1year PFS: 58.3% | Any-grade CRS 94%, ≥grade 3 CRS 22%; any-grade NTX 0% | [16] | |
CT103A ChiCTR2000033946 Phase I/II | R/RMM at least 3 prior lines n = 71 | LD chemotherapy followed by 1 × 106 CAR-T cells/kg | ORR: 94.4% | Any-grade CRS 93%, ≥grade 3 CRS 2.8%; any-grade NTX 1.4% (grade 2) | [17] | |
BB212 NCT02658929 Phase I | R/RMM at least 3 prior lines n = 33 | LD chemotherapy followed by 50–800 × 106 CAR-T cells/kg | ORR: 85%; median PFS 11.8 months | Any-grade CRS 76%, ≥grade 3 CRS 6%; ≥grade 3 NTX 3% | [18] | |
BB212 NCT03361748 Phase II | R/RMM at least 3 prior lines n = 128 | LD chemotherapy followed by 150–450 × 106 CAR-T cells/kg | ORR: 73%; median PFS 8.6 months | Any-grade CRS 84%, ≥grade 3 CRS 5%; ≥grade 3 NTX 3% | [19] | |
anti-CD19 CAR-T cells | CTL019 NCT02135406 Phase I | R/RMM at least 2 prior lines n = 10 | ASCT followed by 50 × 106 CAR-T cells/kg | ORR: 80% | Any-grade CRS 10%, ≥grade 3 CRS 0%; no NTX reported | [20] |
anti-CD19 CAR-T cells combined with anti-BCMA CAR-T cells | NCT 03196414 Phase I/II | R/RMM at least 1 prior lines n = 10 | LD chemotherapy followed by 1 × 107 CD19- CAR-T cells/kg day0, 3–6.5 × 107 BCMA-CAR-T cells/kg day 1,2 | ORR: 90% | Any-grade CRS 100%, ≥grade 3 CRS 10%; no NTX reported | [21] |
ChiCTR-OIC-17011272 Phase II | R/RMM at least 5 prior lines n = 22 | LD chemotherapy followed by 1.0 × 106 CD19- CAR-T cells/kg day0, 1 × 106 BCMA-CAR T cells/kg day 0 | ORR: 95% | Any-grade CRS 90%, ≥grade 3 CRS 5%; Any-grade NTX 9.5% | [22] | |
SZ-MM-CART02 NCT 03455972 Phase I/II | NDMM High Risk n = 9 | ASCT followed by 1 × 107 CD19-CAR-T cells/kg day0, 5 × 107 BCMA-CAR-T cells/kg day 1,2 | ORR: 100% | Any-grade CRS 100% | [23] | |
anti-CD38 and anti-BCMA dual-target CAR-T cells | BM38 ChiCTR1800018143 Phase I | R/RMM at least 2 prior lines n = 23 | LD chemotherapy followed by 0.5–4 × 106 CAR-T cells/kg | CR: 87%; median PFS 17.2 months | Any-grade CRS 87%, ≥grade 3 CRS 35%; ≥grade 3 NTX 0% | [24] |