ALLO-715: UNIVERSAL Study Targeting B Cell Maturation Antigen (BCMA) in Relapsed/Refractory Multiple Myeloma
Primary objective
Key secondary objectives
- Recommended ALLO-715 Phase 2 dose and lymphodepletion regimen
- Anti-tumor activity (ORR, duration of response, PFS, and MRD)
- ALLO-715 cellular kinetics (blood levels of anti-BCMA CAR T cells)
- ALLO-647 pharmacokinetics (serum ALLO-647 concentrations)
Key eligibility criteria
- Relapsed/Refractory Multiple Myeloma
- ≥ 3 prior therapies, including an IMiD, a proteasome inhibitor, and an anti-CD38 antibody
- Refractory to last prior therapy
- ECOG 0 or 1
- No donor-specific antibodies
- No bridging therapy allowed
Treatment
- Dose escalation: 40, 160, and 320 x 106 CAR+ cells
Lymphodepletion
- ALLO-647: 13 to 30 mg x 3 days
- Fludarabine: 30 mg/m2/d x 3 days
- Cyclophosphamide: 300 mg/m2/d x 3 days