Allogene’s ALLO-316 achieved a 31% confirmed response rate in CD70-high advanced renal cell carcinoma, with durable responses in the Phase 1 TRAVERSE study.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Allogene Therapeutics has reported complete Phase 1 results from the TRAVERSE study evaluating ALLO-316, an investigational allogeneic CD70-directed CAR T-cell therapy, in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). Published in the Journal of Clinical Oncology, the findings showed a 31% confirmed objective response rate (ORR) among patients with high CD70-expressing tumors treated with the recommended Phase 2 regimen. Responses remained durable, with all responders progression-free at the time of analysis and the longest ongoing response exceeding 18 months.
The study was conducted through a five-year collaboration with The University of Texas MD Anderson Cancer Center. ALLO-316 also demonstrated robust CAR T-cell expansion, persistence, and tumor infiltration after standard lymphodepletion, providing clinical validation of Allogene’s Dagger® technology platform.
Scientific and Clinical Context
Renal cell carcinoma remains difficult to treat once patients progress after immune checkpoint inhibitors and tyrosine kinase inhibitors. Although CAR T-cell therapies have transformed treatment for several hematologic cancers, achieving durable activity in solid tumors has proven considerably more challenging because of limited CAR T expansion and persistence.
ALLO-316 targets CD70, a protein frequently overexpressed in renal cell carcinoma. The therapy incorporates the company’s Dagger® technology, which targets both CD70-positive tumor cells and activated host T cells, helping reduce immune rejection while promoting CAR T-cell expansion without intensified lymphodepletion.
TRAVERSE Phase 1 Findings
The Phase 1 TRAVERSE trial (NCT04696731) enrolled 51 patients with Stage IV RCC, including 46 patients who received ALLO-316. Median follow-up reached 28.8 months.
The Phase 1b expansion cohort evaluated the recommended Phase 2 regimen consisting of a single infusion of 80 million CAR T cells following three days of standard fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) lymphodepletion. Patients had disease resistant to immune checkpoint blockade and at least one prior tyrosine kinase inhibitor, while 41% had previously received belzutifan.
Among the 20 treated patients in Phase 1b, the confirmed ORR was 25%, increasing to 31% (5 of 16 patients) in those with CD70 tumor proportion score (TPS) ≥50%. No responses occurred in patients with CD70 TPS below 50%.
Median duration of response had not been reached, with responses lasting 8 to more than 18 months. Median overall survival was 15.2 months across the Phase 1b population, while median overall survival remained unreached in the CD70-high subgroup.
Safety Profile Supports Continued Development
The safety profile was consistent with expected toxicities following lymphodepletion and CAR T-cell therapy. The most common Grade 3 or higher adverse events were hematologic, including neutropenia, leukopenia, anemia, and thrombocytopenia.
Cytokine release syndrome (CRS) occurred in 68% of patients and was limited to Grade 1 or 2 events. Immune effector cell-associated hemophagocytic syndrome (IEC-HS) was reported in 36% of patients, with only two Grade 3 or higher events. Investigators reported that protocol-defined diagnostic and management strategies effectively controlled these events. No Grade 5 adverse events occurred in the Phase 1b cohort.
Executive Perspective and Path Forward
According to Allogene, the study provides clinical evidence that an allogeneic CAR T-cell therapy can achieve durable expansion and meaningful antitumor activity in metastatic solid tumors using conventional lymphodepletion. Investigators also highlighted the encouraging durability of responses in patients with high CD70 expression, a population with limited treatment options after standard therapies fail.
ALLO-316 previously received Fast Track Designation from the U.S. Food and Drug Administration in 2023 and Regenerative Medicine Advanced Therapy (RMAT) designation in October 2024 for advanced or metastatic RCC. The Phase 1 findings support continued clinical development of ALLO-316 and further evaluation of the Dagger® platform across additional allogeneic CAR T-cell programs targeting both solid tumors and hematologic malignancies.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.