other material
confidence high
sentiment neutral
materiality 0.60
Allogene initiates Phase 2 ALPHA2 trial of ALLO-501A in r/r LBCL; plans EXPAND trial for ALLO-647
Allogene Therapeutics, Inc.
- ALPHA2 trial will enroll ~100 r/r LBCL patients with single 120M CAR+ cell dose; primary endpoint ORR.
- EXPAND trial (~70 patients) randomized to assess ALLO-647 contribution to lymphodepletion regimen.
- FDA cleared manufacturing from CF1 using non-Alloy process; Alloy process being implemented at CF1.
- Company plans to seek FDA approval based on ALPHA2 and EXPAND trials assuming favorable outcomes.
- CD19 program update, including longer-term Phase 1 follow-up with Alloy process, expected end of 2022.