Table 2:
BCMA-CAR T therapy trials.
| NCI | MSK | University of Pennsylvania | Bluebird 2121 | Nanjing Legend | |
|---|---|---|---|---|---|
| Authors/presentation | Ali et al, Blood 2016. 128:1688 Brudno et al, ASH 2017 | Mailankody et al, ASH 2018. | Cohen et al, ASH 2016 Cohen et al, ASH 2017 Cohen et al, JCI 2019 | Berdeja et al. ASH 2017 Raje et al. ASCO 2018 Raje et al. NEJM, 2019. | Fan et al, ASCO 2017 Zhao et al. J Hem Onc 2018 |
| n | 26 | 11 | 24 | 43 | 57 |
| vector | Retroviral vector | Retrovial Vector | Lentiviral vector | Lentiviral vector | Lentiviral vector |
| Costimulatory domain | CD28 | 4–1BB | 4–1BB | 4–1BB | 4–1BB |
| Activation domain | CD3-zeta | CD3-zeta | CD3-zeta | CD3-zeta | CD3-zeta |
| conditioning | Cyclophospham ide+fludarabine | 3 day Cy+Flu (300 + 30mg/m2) or 1 day Cy (3000mg/m2) | With or without Cy | Cy+Flu (day −5, −4 and −3) | Cy |
| Dosing | 4 dose levels: 0.3 ×; 1 ×; 3 ×; and 9 × 106 CAR T cells/kg | 3+3 Dose Escalation: 3 at 1 × 106 3 at 150 × 106 4 at 450 × 106 1 at 800 × 106 | 3 cohorts: 1–5 × 108 CAR T; Cy 1.5g/m2 + 1–5 × 107 CAR T; Cy 1.5g/m2 + 1–5 × 108 CAR T (Cy: day −3; CAR split: 10% day 0; 30% day 1; 60% day 2 | 1 infusion; Dose escalation: 50×, 150×, 450×, and 800× 106 | 0.07 to 2.1 × 106 CAR T cells/kg |
| Prior lines Of treatment (median) | 11 | 6 | 7. 100% PI and IMiD refractory; 67% dara-refractory; 95% high risk cytogenetics. | 7–8 | More than 2 |
| CRS | On the highest dose, 92% had CRS (grade 1–4) | 6/10 And 3/4 at ≥450×106 | Cohort 1: 8/9; Cohort 2 and 3: 9/12 | Manageable; 27/43 (63%): 2: >grade 3, no DLTs, No neurotoxicities | Grade 3 AE: 37/57 (65%); CRS: 51/57 (90%); grade 3 CRS 4/57 (7%) |
| Response | On the highest dose, 9/11 (82%) ORR: 2 sCR, 5 VGPR, 2 PR | At ≥450×106 2/5 still at VGPR and 3/5 have progressed. 5/11 VGPR | Cohort 1: 6/9 (1 sCR, 2 VGPR, 1PR, 1MR) Cohort 2: 2/5 (1 PR, 1 MR) Cohort 3: 5/6 (1 CR, 3 PR, 1 MR)Cohort 1: 6/9 (1 sCR, 2 VGPR, 1PR, 1MR) Cohort 2: 2/5 (1 PR, 1 MR) Cohort 3: 5/6 (1 CR, 3 PR, 1 MR) | On the highest dose, ORR: 95.5%; CR 50%; VGPR 36.4%, PR 9.1% | ORR: 88%: 39/57 (68%) CR; 3/57 (5%) VGPR; 8/57 (14%) PR |
| MRD | 8/10 MRD negative by flow | Not Assessed | 16/16 MRD negative: PFS: 17.7 Months | 36/57 (63%) MRD negative at 1 × 104 PFS: 15 months |