Table 1.
Dose groups – lymphodepletion and cell doses.
| Dose group | Lymphodepletion regimen | Transduced cell dose (range) | Patient ID |
|---|---|---|---|
| Dose group 1 | Cyclophosphamide 600 mg/m2/day and fludarabine 30 mg/m2/day on days -7, -6, and -5 | 0.1×109 (0.08×109 to 0.12×109) | 1–3 |
| Dose group 2 a | Cyclophosphamide 600 mg/m2/day and fludarabine 30 mg/m2/day on days -7, -6, and -5 | 1×109 (0.5×109 to 1.2×109) | – |
| Dose group 3 | Cyclophosphamide 600 mg/m2/day on days -7, -6, and -5 and fludarabine 30 mg/m2/day on days -7, -6, -5, and -4 | 5×109 (>1.2×109 to 6×109) | 4–6 |
| Expansion group | Cyclophosphamide 600 mg/m2/day on days -7, -6, and -5 and fludarabine 30 mg/m2/day on days -7, -6, -5, and -4 | 5×109 (1.2×109 to 15×109) | 7–10 |
a
No patients were treated in dose group 2 as this dose group was removed from the protocol based on the Safety Review Committee assessment of safety data from patients in an identical dose group with the same investigational agent in Study ADP-0022-003 (NCT02592577).