Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company advancing the development of allogeneic CAR T (AlloCAR T™) therapies for cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALLO-329, an investigational allogeneic CAR T product. The clearance enables the initiation of a Phase 1 rheumatology basket study, RESOLUTION, to evaluate ALLO-329 in patients with systemic lupus erythematosus (including lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis.

The RESOLUTION trial, scheduled to begin in mid-2025, will assess the safety and preliminary efficacy of ALLO-329. The study features an innovative design leveraging Allogene’s clinically validated Dagger® technology, which enhances CAR T cell expansion and reduces the risk of immune rejection. The trial includes two lymphodepletion arms: one using cyclophosphamide alone, a standard rheumatology treatment, and another eliminating lymphodepletion entirely. This approach aims to simplify treatment protocols and improve patient access to CAR T therapy.

“One year ago, we introduced the concept of ALLO-329, an allogeneic CAR T product designed to address the unique challenges of autoimmune diseases. Today, with FDA clearance of our IND, that vision is becoming a reality,” said David Chang, M.D., Ph.D., President, CEO, and Co-Founder of Allogene. “This milestone reflects the extraordinary pace of our progress, driven by Allogene’s expertise in research, manufacturing, and clinical development. By combining the immune-resetting potential of allogeneic CAR T with our Dagger® technology, which may reduce or eliminate the need for lymphodepletion, we are taking a transformative step forward. Success in this basket study could validate our approach and open the door to expanding into a broad range of autoimmune indications.”

 

Next-Generation Approach to Autoimmune Therapy

ALLO-329 represents a novel dual-targeting CAR T therapy designed to address both B-cell and T-cell dysfunction, key drivers of immune dysregulation in autoimmune diseases. The product targets CD19+ B cells and CD70+ activated T cells, offering a comprehensive therapeutic strategy. Additionally, ALLO-329 incorporates Allogene’s proprietary Dagger® technology, which enhances immune resistance and may reduce or eliminate the need for lymphodepletion prior to cell infusion. If successful, this advancement could simplify treatment protocols, enable large-scale manufacturing of up to 60,000 doses annually, and expand access to CAR T therapy across a wide range of autoimmune diseases.

 

About ALLO-329

ALLO-329 is an investigational CD19/CD70 dual-targeting AlloCAR T™ product under development for autoimmune diseases. Utilizing CRISPR-based site-specific integration for dual CAR expression, ALLO-329 targets both CD19+ B cells and CD70+ T cells, which are implicated in autoimmune disease pathogenesis. The incorporation of Allogene’s Dagger® technology aims to reduce or eliminate the need for lymphodepletion, addressing a significant barrier to CAR T therapy adoption in autoimmune indications.

 

About Allogene Therapeutics

Allogene Therapeutics, headquartered in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer and autoimmune diseases. Led by a team with extensive cell therapy expertise, Allogene is building a pipeline of “off-the-shelf” CAR T cell product candidates designed to deliver readily available, scalable, and reliable cell therapies to more patients.

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