Allogene’s ALLO-316 Allogeneic CAR T Achieves First Durable Remissions with 31% ORR in Phase 1 Metastatic Renal Cell Carcinoma Trial

July 19, 2026

BioSpace USA

Overview

Allogene Therapeutics announced compelling Phase 1 results for ALLO-316, a CD70-targeted allogeneic CAR T therapy, demonstrating a 31% confirmed objective response rate and the first durable remissions in metastatic renal cell carcinoma. The study, published in the Journal of Clinical Oncology, utilized Allogene’s Dagger technology, which enabled robust CAR T cell expansion, persistence, and tumor infiltration with standard lymphodepletion. This breakthrough addresses critical challenges in solid tumor CAR T therapy, paving the way for broader access and more rapid treatment for patients with aggressive cancers.

In Depth

Key Findings

Allogene Therapeutics has published full Phase 1 clinical trial data for its allogeneic CAR T-cell therapy, ALLO-316, in the Journal of Clinical Oncology. The study revealed a 31% confirmed objective response rate (ORR) and, critically, the first durable remissions achieved with an allogeneic CAR T-cell therapy in solid tumors, specifically in patients with high CD70-expressing metastatic renal cell carcinoma.

Technical / Clinical Details

ALLO-316 is a CD70-targeting allogeneic CAR T-cell investigational therapy, incorporating Allogene’s proprietary Dagger® technology.
The Phase 1 trial was conducted in patients with heavily pretreated advanced or metastatic renal cell carcinoma (ccRCC).
Clinical data showed that approximately half of the treated patients achieved disease control, with the 31.3% ORR observed in patients with high CD70 expression.
The Dagger technology proved instrumental, facilitating robust CAR T-cell expansion, sustained presence, and effective tumor infiltration using only standard lymphodepletion. This addresses two significant hurdles for CAR T therapies in solid tumors: achieving sufficient cell proliferation and persistence in the tumor microenvironment.

Background & Context

Traditional autologous CAR T-cell therapies, which rely on genetically modifying a patient’s own cells, are associated with lengthy manufacturing times and high costs. These limitations often render them unsuitable for patients with rapidly progressing diseases who require urgent treatment. Allogeneic CAR T-cell therapies, derived from healthy donor T-cells, represent a crucial advancement by offering a potential “off-the-shelf” solution, aiming to improve accessibility and expedite treatment initiation. While CAR T-cell efficacy in solid tumors has historically lagged behind that in hematologic malignancies, the results for ALLO-316 signal a promising shift, demonstrating the potential to extend this powerful modality to more challenging cancer types.

Strategic Significance & Outlook

The successful Phase 1 results mark a pivotal milestone in the clinical development of allogeneic CAR T-cell therapy for renal cell carcinoma and other solid tumors. The achievement of durable remissions is particularly significant for patients battling difficult-to-treat RCC, offering a new therapeutic horizon. Further larger-scale clinical trials will be essential to comprehensively evaluate the safety and efficacy of ALLO-316. This advancement is expected to accelerate the evolution of cell therapy in solid oncology, potentially transforming treatment paradigms and improving outcomes for a broader patient population.

Source: https://www.biospace.com/press-releases/allogene-therapeutics-announces-journal-of-clinical-oncology-publication-of-phase-1-results-of-allo-316-highlighting-first-durable-remissions-following-allogeneic-car-t-for-treatment-of-metastatic-solid-tumors

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