Designations Follow Recent Investigational New Drug (IND) Application Clearance for the RESOLUTION Basket Study of ALLO-329 in Rheumatology
Dual CD19/CD70 CAR T Specifically Designed to Enhance Therapeutic Benefit, Expanding Treatment Potential Across a Range of Autoimmune Indications
Leverages Proprietary Dagger® Technology to Reduce or Eliminate Lymphodepletion, Potentially Expanding Access to a Broader Patient Population
Phase 1 RESOLUTION Trial Initiation Planned for Mid-2025 with Initial Proof-of-Concept by Year-End 2025
April 07, 2025 -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with:
active refractory moderate-to-severe systemic lupus erythematous (SLE);
active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and
active refractory diffuse systemic sclerosis (SSc).
"Receiving these designations for ALLO-329 underscores the versatility and transformative promise of this next-generation allogeneic CAR T investigational product in redefining the autoimmune treatment landscape," said Zachary Roberts, M.D., Ph.D., EVP of Research and Development and Chief Medical Officer of Allogene. "Leveraging our extensive expertise, we've developed this off-the-shelf CAR T specifically for autoimmune diseases, prioritizing both scalability and the reduction or elimination of lymphodepletion – a key barrier in this patient population."
The Company expects to initiate the Phase 1 RESOLUTION basket trial in mid-2025. The trial is designed to evaluate the safety and preliminary efficacy of ALLO-329 in patients with SLE, IIM, and SSc. This innovative trial design, which leverages the clinically validated Dagger® technology to drive CAR T cell expansion and prevent rejection, includes two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone, which is used by rheumatologists, and another that eliminates lymphodepletion entirely. Proof-of-concept from the RESOLUTION trial is expected by year-end 2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases.
FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.
ALLO-329 is a CD19/CD70 dual AlloCAR T™ investigational product being developed for the treatment of autoimmune diseases. ALLO-329 utilizes CRISPR-based site-specific integration for dual CAR expression. This approach targets both CD19+ B cells and CD70+ T cells, which play a role in autoimmune disease pathogenesis. Additionally, ALLO-329 incorporates Allogene's clinically validated Dagger® technology, designed to reduce or eliminate the need for lymphodepletion, a pre-treatment regimen that may be a significant barrier to CAR T cell therapy adoption in autoimmune indications.
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
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