Phase 1 study (
DISEASE PROGRESSION
Patients who met the pre-screening requirements were then screened for eligibility criteria for this phase 1 trial (Leukapheresis was performed to obtain CD3Patients received LD chemotherapy consisting of fludarabine 30 mg/mThis phase 1 trial was conducted using a 3 + 3 design and involved dose escalation of afami-cel across dose Groups 1–3 and an expansion group. Dose ranges (total transduced cell number) were 0.08 × 10Evaluation of safety and tolerability was conducted at each study visit as follows: baseline; days −7 to −3; days 1–5; days 8, 15, 22, 29, 36, 43, 57, 71, 85, 127 and 169; every 3 months until year 2; every 6 months from years 2 to 5 or until disease progression; and at completion.