AMBIGUOUS RESULTS

Allogene's ALLO-316 hits 31% response rate in CD70-high kidney cancer

Complete Phase 1 TRAVERSE data show durable responses with an allogeneic CAR T in a population that had exhausted checkpoint inhibitors and TKIs, though the trial remains a 51-patient, uncontrolled study.

By AppliedXLJuly 15, 2026Trial NCT04696731

Executive Summary

Allogene's CD70-targeted allogeneic CAR T produced confirmed responses lasting from several months to more than a year and a half in a heavily pretreated kidney cancer population, with survival data still immature.
The trial's registered goal was to establish a tolerable dose and regimen; the efficacy figures being emphasized now sit outside that original endpoint, and the sponsor has surfaced a subgroup result alongside a lower whole-cohort figure.
CD70 is a target several companies have tried and abandoned in kidney cancer, and Allogene's own tally shows most prior attempts in this pairing ended in termination, making TRAVERSE among the more advanced programs still standing on this target in this disease.
Allogene is framing the durability and expansion data as validation of its broader Dagger allogeneic manufacturing technology, a claim that would extend beyond this single trial if borne out in the company's other CAR T programs.
The data mark antitumor activity in a tumor setting where CAR T has largely disappointed, but the trial's design and the timing of disclosure temper how much can be concluded before a controlled study runs.

The disclosure

Allogene Therapeutics, Inc. announced on July 15, 2026 that complete Phase 1 data from its TRAVERSE trial of ALLO-316 were published in the Journal of Clinical Oncology. ALLO-316 is a CD70-directed allogeneic CAR T therapy built on Allogene's Dagger technology, tested in NCT04696731, a Phase 1 study of advanced or metastatic clear cell renal cell carcinoma. Across the full trial, 51 patients with Stage IV disease enrolled and 46 received ALLO-316, with a median follow-up of 28.8 months. The Phase 1b expansion, evaluating the recommended Phase 2 regimen of 80 million CAR T cells after standard fludarabine/cyclophosphamide lymphodepletion, enrolled 22 safety-population patients, all resistant to checkpoint inhibitors and at least one tyrosine kinase inhibitor, with 82% having received two or more prior TKIs and 41% having received prior belzutifan. Allogene+1

The result

In the Phase 1b expansion, confirmed response rate was 25% across all treated patients and 31% in the subset with CD70 tumor proportion score of 50% or higher. Median duration of response had not been reached at the time of analysis, with a 95% confidence interval spanning 6.9 months to not estimable, and responses ranged from 8 to more than 18 months. Median overall survival in the Phase 1b cohort was 15.2 months, with a 95% confidence interval of 4.6 months to not estimable. Allogene said the safety profile was manageable, with proactive diagnostic and management strategies mitigating immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), and characterized the profile as consistent with known CAR T toxicities. Allogene

The endpoint gap

TRAVERSE's registered primary outcome measure is the proportion of patients experiencing dose-limiting toxicity with ALLO-647 combined with fludarabine/cyclophosphamide ahead of ALLO-316 dosing, a safety and dose-finding endpoint, not the response-rate figures now driving the headline result. The published response rate leads with the CD70-high subgroup (31%) rather than the broader Phase 1b population (25%), the specific pattern the underlying data flagged as emphasis on a post-hoc subgroup. Allogene's chief executive Zachary Roberts said the results provide "clinical validation of our Dagger technology platform" with "direct read-through to our broader clinical and preclinical pipeline of next-generation AlloCAR T candidates". Samer Srour of The University of Texas MD Anderson Cancer Center, the trial's academic partner, said patients in TRAVERSE had largely exhausted available therapies and faced survival "often measured in months" before treatment. Allogene

The competitive field

CD70 has drawn a cluster of Phase 1 efforts in renal cell carcinoma, and the pairing has a 75% termination rate across three companies at Phase 1, with only one prior trial in this target-indication combination reaching completion. Direct comparators sharing both the CD70 target and CAR-T modality in this indication include Adicet Therapeutics' ADI-270 (NCT06480565) and CRISPR Therapeutics' CTX131 (NCT05795595), both also in Phase 1/2 testing. Antibody-drug conjugate and monoclonal antibody approaches targeting CD70, including Seagen's SGN-CD70A and Amgen's AMG 172, were tested in earlier RCC trials but differ in modality from Allogene's cell-therapy approach. ALLO-316 previously received FDA Fast Track designation in March 2022 for CD70-positive advanced or metastatic RCC.

Timing and trial status

The trial's primary completion date moved from December 2022 to August 2025 and then to October 2025, a cumulative delay of more than two years, before the study moved to Active, not recruiting status in September 2025. That timeline places the July 2026 publication roughly nine months after the registry's stated primary completion date. Allogene said the findings support continued clinical development of ALLO-316 and evaluation in further studies, without specifying a next trial or regulatory filing timeline. NCT04696731+1

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