Key Catalyst Highlights for 2026

• Interim futility analysis of minimal residual disease (MRD) clearance from the pivotal Phase 2 ALPHA3 trial involving cemacabtagene ansegedleucel (Cema-Cel) is slated for early Q2 2026.
• Initial proof-of-concept data for ALLO-329, a dual CD19/CD70 AlloCAR T designed to reduce lymphodepletion in autoimmune diseases, is expected by the end of 1H 2026.
• Allogene's cash runway is projected to extend into the second half of 2027.

Building a Sustainable CAR T Platform

Allogene's development has spanned nearly eight years and involved over 200 patients across six clinical studies. The company's off-the-shelf CAR T platform is crafted to provide consistent clinical utility, broaden patient access, and ensure predictable manufacturing. This adaptability is essential for transitioning cell therapy into routine medical use.

"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene, with clinical milestones that could set new standards in the field," said David Chang, M.D., Ph.D., the company’s President and CEO. “We aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."

Driving Innovation in Oncology with Cema-Cel

Allogene's lead program, Cema-Cel, is currently undergoing evaluation in the Phase 2 ALPHA3 trial, focused on preventing recurrence of large B-cell lymphoma (LBCL) through early MRD-guided consolidation therapy. This strategy incorporates Cema-Cel as a “7th cycle” of treatment, enhancing patient access by enrolling candidates from both academic and community cancer centers.

An interim futility analysis in early Q2 2026 is set to test if early intervention can improve MRD clearance by 25-30% compared to mere observation, potentially marking a significant advancement in LBCL management.

ALLO-329: Revolutionizing Autoimmune Disease Treatment

ALLO-329 represents a next-gen dual-targeted AlloCAR T that leverages Allogene’s Dagger® technology to selectively deplete CD70-positive T cells, which are responsible for rejecting AlloCAR T products. This innovation may reduce the reliance on conventional cytotoxic lymphodepletion and increase treatment accessibility for young patients and those with moderate diseases.

The Phase 1 RESOLUTION trial is currently recruiting patients across various autoimmune conditions, including systemic lupus erythematosus and lupus nephritis, with initial data anticipated by the end of 1H 2026.

ALLO-316: Expanding CAR T Potential to Solid Tumors

Allogene's ALLO-316 program has shown early promising results in patients with renal cell carcinoma (RCC), indicating potential benefits of CAR T in solid tumor environments. The Phase 1 trial has recorded a 31% objective response rate (ORR) with durable effects observed for over six months post-treatment.

"Each of our programs represents a frontier where our products can genuinely alter disease trajectories," stated Zachary Roberts, M.D., Ph.D., Allogene's EVP of Research and Development. "These advancements demonstrate that allogeneic CAR T is a clinical reality advancing in multiple significant therapeutic areas."

Financial Outlook and Future Plans

Allogene Therapeutics anticipates its financial resources will sustain operations through the second half of 2027, excluding potential business development impacts. The company is positioned to leverage this stable financial runway to explore opportunities across high-value therapeutic categories with its differentiated allogeneic CAR T platform.

About Allogene Therapeutics

Allogene Therapeutics is a clinical-stage biotechnology company headquartered in South San Francisco, pioneering allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies aimed at treating various cancers and autoimmune diseases.