Allogene's ALLO-316 Publishes First Durable Remissions From Allogeneic CAR T in Solid Tumors

Allogene Therapeutics announced the publication of complete phase 1 results from the TRAVERSE study of ALLO-316 in the Journal of Clinical Oncology, reporting what the company describes as the first durable remissions achieved with an allogeneic CAR T therapy in a solid tumor setting.¹

Twenty-two heavily pretreated patients with Stage IV renal cell carcinoma (RCC) enrolled in the Phase 1b portion of the trial, and 20 received a single 80-million-cell dose of ALLO-316 following standard fludarabine/cyclophosphamide lymphodepletion. The confirmed overall response rate was 25% (5 of 20 patients), rising to 31% (5 of 16 patients) among those with high CD70 tumor proportion scores of 50% or greater. All confirmed responders remained progression-free at the time of analysis, with responses ranging from 8 to 18-plus months and median overall survival not yet reached.¹

How does ALLO-316 address the allogeneic rejection problem?

ALLO-316 is built on Allogene's Dagger technology, designed to address one of the central challenges facing off-the-shelf, allogeneic CAR T products: rejection by the recipient's own immune system. By targeting CD70-expressing tumor cells as well as CD70-positive alloreactive host T cells simultaneously, ALLO-316 is designed to support CAR T-cell expansion and persistence without requiring intensified lymphodepletion, the more aggressive immune-suppressing conditioning regimens that allogeneic cell therapies have often needed to prevent host rejection. In TRAVERSE, this dual-targeting design translated into robust CAR T-cell expansion, durable persistence, and evidence of tumor infiltration using only standard lymphodepletion, outcomes Allogene said validate Dagger as a next-generation allogeneic CAR T platform with potential relevance across its broader pipeline.

Why does CD70 make sense as a target in renal cell carcinoma?

CD70 is a member of the tumor necrosis factor superfamily that is aberrantly overexpressed across a range of malignancies, including clear cell and sarcomatoid RCC, while showing limited expression in normal tissue, a combination that makes it an attractive antigen for targeted therapy with reduced risk of off-tumor toxicity.¹ CD70 expression has also been shown to be maintained at metastatic sites of RCC and is enriched in the subtypes of the disease with the most aggressive clinical behavior, supporting the rationale for targeting it specifically in the metastatic, treatment-refractory population enrolled in TRAVERSE.²

RCC accounts for roughly 90% of the approximately 80,450 new kidney and renal pelvis cancer cases expected in the US in 2026, with an estimated 15,160 deaths from the disease this year.³ Patients with metastatic RCC who have exhausted standard therapies, the population studied in TRAVERSE, often face limited treatment options and a median survival measured in months, underscoring the unmet need that a durable single-dose cell therapy response could address.

Zachary Roberts, MD, PhD, president and chief executive officer of Allogene, said, "TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field."

What was the safety profile?

Allogene described ALLO-316's safety profile as manageable, with proactive diagnostic and management strategies proving effective in mitigating immune effector cell-associated hematotoxicity syndrome (IEC-HS), a toxicity that has been a recognized concern with CAR T therapies more broadly. The company said this safety management was achieved while preserving efficacy, an important balance for a therapy intended to be delivered as a single, off-the-shelf dose rather than a customized, patient-derived product.

What happens next?

TRAVERSE is being conducted as part of a strategic five-year collaboration between Allogene and the University of Texas MD Anderson Cancer Center. With full phase 1 data now published in a peer-reviewed journal, the durability and expansion data reported in TRAVERSE may inform how Allogene positions Dagger technology across its broader clinical and preclinical allogeneic CAR T pipeline, both in oncology and in the autoimmune disease programs the company has also been advancing.

References

1. 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. (2026 Jul 15). GlobeNewswire. https://www.globenewswire.com/news-release/2026/07/15/3327728/0/en/allogene-therapeutics-announces-journal-of-clinical-oncology-publication-of-phase-1-results-of-allo-316-highlighting-first-durable-remissions-following-allogeneic-car-t-for-treatme.html
2. Zang PD, Angeles A, Pal SK. (2025 Jan). CD70: An Emerging Anticancer Target in Renal Cell Carcinoma and Beyond. Annu Rev Med. https://pubmed.ncbi.nlm.nih.gov/39570653/
3. Adam PJ, Terrett JA, Steers G, et al. (2006 Aug). CD70 (TNFSF7) is expressed at high prevalence in renal cell carcinomas and is rapidly internalised on antibody binding. Br J Cancer. https://pubmed.ncbi.nlm.nih.gov/16892042/