Allogene Therapeutics presented positive Phase 1 data from its TRAVERSE study of ALLO-316, an allogeneic CAR T therapy, for renal cell carcinoma (RCC) at the 2025 ASCO Annual Meeting. The study showed a 31% confirmed response rate in patients with advanced or metastatic RCC and a high CD70 Tumor Proportion Score (TPS ≥ 50%), with four out of five responders maintaining remission, including one lasting over 12 months. This is the first allogeneic CAR T product to demonstrate potential in solid tumors.
This data is exciting because solid tumors have historically been resistant to CAR T therapies, which have shown success in blood cancers. The 31% response rate in a heavily pre-treated patient population is a notable advancement, suggesting ALLO-316 could become a valuable treatment option for advanced RCC, where patient prognosis is typically poor after standard therapies fail. The durability of responses seen so far, with one exceeding 12 months, hints at the potential for long-term disease control, a critical factor in cancer treatment. Moreover, Allogene’s proprietary Dagger technology allowed for the use of a standard lymphodepletion regimen, simplifying treatment administration compared to some other CAR T cell therapies.
Twenty-two patients with advanced RCC, who had previously failed multiple treatments including immune checkpoint blockers and at least one tyrosine kinase inhibitor, were enrolled in the Phase 1b expansion cohort. Of these, 20 received a single dose of ALLO-316 after standard lymphodepletion. Sixteen patients had a CD70 TPS ≥ 50%. The most frequent adverse events were hematologic, consistent with lymphodepletion and CAR T therapy, with no Grade 5 events reported. While immune effector cell-associated neurotoxicity syndrome (IEC-HS) was observed, refined diagnostic and management strategies effectively mitigated it.
This positive data from the TRAVERSE study strengthens the potential of ALLO-316 as a viable treatment for advanced RCC. The confirmed responses and their durability offer much-needed hope for patients with limited options. Further research will be crucial to confirm these findings in larger trials and explore the therapy’s potential in other CD70-expressing cancers. This success also validates Allogene’s Dagger technology platform, which could pave the way for the development of additional allogeneic CAR T therapies against solid tumors.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
