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

About this update from Allogene Therapeutics, Inc.

SOUTH SAN FRANCISCO, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- 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 the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology . TRAVERSE is being conducted as part of a strategic five-year collaboration with The University of Texas MD Anderson Cancer Center. ALLO-316, Allogene's CD70-targeting AlloCAR T investigational therapy incorporating the Dagger® technology, achieved robust expansion, tumor infiltration, and durable antitumor activity in a solid tumor setting. "TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "CAR T has transformed hematologic malignancies while solid tumors have remained one of the field's most difficult challenges. When we designed ALLO-316 with the Dagger® technology, our goal was to address two of the most persistent barriers in solid tumors – achieving robust CAR T expansion with standard lymphodepletion and translating that biology into durable responses. These results show that a well-designed allogeneic CAR T product, developed for a defined population, can expand, persist, and produce durable responses in metastatic, treatment refractory solid tumors. Importantly, the robust CAR T expansion and durable persistence in this trial provides clinical validation of our Dagger® technology platform and has direct read-through to our broader clinical and preclinical pipeline of next-generation AlloCAR T candidates."   Across the full Phase 1 TRAVERSE trial, 51 patients with Stage IV disease were enrolled, of whom 46 received ALLO-316 and had a median follow-up time of 28.8 months. The Phase 1b expansion cohort evaluated the safety and efficacy of the recommended Phase 2 regimen – ALLO-316 at a dose of 80M CAR T cells following a standard FC lymphodepletion regimen (fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days). The 22 patients in the Phase 1b safety population all had RCC resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had received ≥2 prior TKIs, and 41% had received prior belzutifan. Twenty of these patients received ALLO-316. Sixteen of the ALLO-316-treated patients in Phase 1b had a high CD70 Tumor Proportion Score (TPS ≥50%). The median time from enrollment to the start of therapy was four days.

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