Table 2.
Comparison of KarMMa (bb2121) and LEGEND-2 (LCAR-B38M) clinical studies
| bb2121 / KarMMa [59] | LCAR-B38M / LEGEND-2 (Xi’an site) [49, 50] | |
|---|---|---|
| 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) |
aCD3 + aCD28 = anti-CD3 and anti-CD28 antibodies. aCD3/CD28 + IL-2 = anti-CD3 and anti-CD28-coated beads plus interleukin-2. cilta-cel = ciltacabtagene autoleucel. CP = cyclophosphamide. CP/Flu = cyclophosphamide plus fludarabine. CR = complete response. CRS = cytokine release syndrome. d = days. Gr. = grade. ide-cel = idecabtagene vicleucel. m = months. MRD = minimal residual disease. n = number. ORR = objective response rate. PFS = progression-free survival. PLT = prior lines of treatment. RD = recommended dose. scFv = single-chain variable fragment. (VG)PR = (very good) partial response. VHH = heavy-chain variable region. Trial # = study registration number in Clinicaltrials.gov (NCT#). y = years
aHigh-risk defined as R-ISS stage 3 and/or high-risk genetics (del(17p), t(4;14), t(14;16))
bData shown for the 450 × 106 dose cohort only