From: Safety and clinical efficacy of BCMA CAR-T-cell therapy in multiple myeloma
bb2121 / KarMMa [59] | ||
---|---|---|
Alternative product name | ide-cel | cilta-cel |
Trial # (study phase) | NCT03361748 (phase II) | NCT03090659 (phase I) |
n of patients | 128 (54 at RD of 450 × 106) | 57 |
Expansion method | aCD3 + aCD28 | aCD3/CD28 + IL-2 |
Loading method | Lentiviral | Lentiviral |
CAR-T structure | Murine scFv | Llama 2xVHH |
Lymphodepletion | CP/Flu | CP |
CAR-T cell dosage(s) | 150–300 to 450 × 106 | 32.3 × 106 (3.3 to 126.2 × 106) |
Patient characteristics | ||
Age (range), y | 61 (33–78) | 54 (27–72) |
Median n PLT (range) | 6 (3–16) | 3 (1–9) |
High-risk featuresa | 51% | 37% |
CRS | 96.3%b | 89.5% |
Gr. 1–2 | 90.7% | 82.5% |
Gr. ≥ 3 | 5.6% | 7.0% |
Median onset (range) | 1d (1–10) | 9d (1–19) |
Median duration (range) | 7d (1–63) | 9d (3–57) |
Tocilizumab use | 67% | 46% |
Neurotoxicity | 20.4%b | 1.8% |
ORR | 82%b | 88% |
MRD− CR | 28% | 68% |
CR | 11% | 5% |
VGPR | 26% | 4% |
PR | 17% | 11% |
Median PFS (95% CI) | 12.1m (8.8–12.3)b | 19.9m (9.6–31) |