Allogene Therapeutics Defines 2026 as Program-Defining Year for CAR T
Allogene Therapeutics outlined 2026 as a program-defining year for allogeneic CAR T, with multiple first-half clinical readouts expected to test, and potentially validate, whether off-the-shelf CAR T can be delivered at biologic-like scale, in real-world settings, across oncology and autoimmune disease. Allogene's lead program, cemacabtagene ansegedleucel, is being evaluated in the pivotal Phase 2 ALPHA3 trial, a randomized study designed to test whether early, MRD-guided consolidation with cema-cel can prevent recurrence of large B-cell lymphoma. ALLO-329 is a next-generation dual-targeted CD19/CD70 AlloCAR T incorporating Allogene's proprietary Dagger technology. The Phase 1 RESOLUTION trial, a 3+3 dose escalation study, is enrolling patients across multiple autoimmune indications. ALLO-316 has demonstrated early, durable responses in heavily pretreated patients with renal cell carcinoma, representing one of the first credible signals that CAR T - autologous or allogeneic - may deliver meaningful benefit in solid tumors. The Phase 1 trial demonstrated: CAR T cell expansion following standard Flu/Cy-based lymphodepletion, providing proof-of-concept for the Dagger technology platform, 31% confirmed ORR with a single ALLO-316 dose1 in patients with high CD70 expression, which represents ~2/3 of clear cell RCC. The Company continues to expect its cash runway to extend into the second half of 2027, excluding any impact from potential business development activities.
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