Table 3.
Multicenter studies with autologous anti-CD19 CAR T-cell therapy for aggressive B-cell lymphomas.
| Variables | ZUMA-1 (Locke et al.76) | JULIET (Schuster et al.82) | TRANSCEND (Abramson et al.87) |
|---|---|---|---|
| Patients enrolled (treated), n | 111 (101) | 165 (111) | 134 (114) 73 in CORE |
| Median follow up | 27.1 months | 19.3 months1 | 12 months |
| Costimulatory domain | CD28 | 4-1BB | 4-1BB |
| CAR T dose (range) | 2.0 × 106 cells/kg | Median, 3.1 × 108 cells | DL1 5.0 × 107 cells2
DL2 1.0 × 108 cells |
| Lymphodepleting regimen | Flu 30 mg/m2 × 3 days Cy 500 mg/m2 × 3 days |
Flu 25/m2x 3 days Cy 250 mg/m2 x3 d or B 90 mg/m2 × 2 days |
Flu 30 mg/m2 × 3 days Cy 300 mg/m2 × 3 days |
| Efficacy | |||
| Best ORR (CR) | 82% (54%) | 52% (40%) | 80% (59%) |
| 6-month ORR (CR) | 41% (36%) | 33% (29%) | 47% (41%) |
| Ongoing ORR (CR) | 39% (37%) | NR | NR |
| mDOR | 11.1 months | Not reached | 9.2 months |
| 12-month PFS | 44% | 66% | NR |
| 18-month PFS | 40% | 64% | NR |
| 12-month OS | 59% | 49% | 63% |
| 18- month OS | 53% | 43% | NR |
1
Median time from infusion to data cutoff.
2
Six patients received double dose of DL1.
B, bendamustine; CR, complete response; Cy, cyclophosphamide; Flu, fludarabine; mDOR, median duration of response; NR, not reported, ORR, overall response rate.