Allogene Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC). This designation aims to expedite the development and review of ALLO-316, an allogeneic CAR T (AlloCAR T™) investigational product. The RMAT designation was based on clinical data from the TRAVERSE trial, which indicated the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy.
ALLO-316 leverages the Dagger® technology to optimize CAR T cell expansion and persistence, aiming to maximize efficacy in solid tumors with a single infusion. This approach seeks to provide a more accessible "off-the-shelf" CAR T therapy option.
Clinical Trial and Data
The ongoing Phase 1 TRAVERSE trial is evaluating the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic RCC. Initial results from the TRAVERSE trial were presented at the American Association for Cancer Research (AACR) Annual Meeting in 2023. Allogene plans to present updated Phase 1 data from the TRAVERSE trial at the Society for Immunotherapy of Cancer (SITC) annual meeting.
RMAT Designation Benefits
The RMAT designation is designed to accelerate the development and review of promising investigational products, including cell therapies. To qualify, a product must be intended to treat, modify, reverse, or cure a serious or life-threatening disease, with preliminary clinical evidence suggesting it can address unmet medical needs. The RMAT designation offers several key advantages, including early and frequent interactions with the FDA to discuss potential surrogate or intermediate endpoints, as well as strategies to meet post-approval requirements, potentially streamlining the path to market approval.
About ALLO-316
ALLO-316 is an AlloCAR T™ investigational product that targets CD70, a protein highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several other cancers, suggesting potential applications for ALLO-316 in both hematologic malignancies and solid tumors. In March 2022, the FDA granted Fast Track Designation (FTD) to ALLO-316.
