A 31% confirmed response rate in a population where every enrolled patient had already failed immune checkpoint blockade and at least one tyrosine kinase inhibitor is not a number the CAR T field produces routinely in solid tumors. Allogene’s full Phase 1 TRAVERSE data, now published in the Journal of Clinical Oncology, show that ALLO-316, their allogeneic CD70-targeting CAR T candidate, achieved that rate specifically in Stage IV renal cell carcinoma patients with high CD70 tumor proportion scores (TPS at least 50%), with every responder still progression-free at the time of analysis and the longest ongoing response exceeding 18 months.
The design choices embedded in these results carry real scientific weight. ALLO-316 uses a standard fludarabine and cyclophosphamide lymphodepletion regimen rather than an intensified conditioning backbone, yet the cells expanded robustly and infiltrated tumor tissue. That matters because the persistent failure of autologous and earlier allogeneic CAR T constructs in solid tumors has largely come down to two problems: poor in vivo expansion and inability to traffic into and survive within the tumor microenvironment. The Dagger technology platform Allogene built into ALLO-316 appears to address both, at least in the CD70-high RCC subset. The TRAVERSE trial enrolled 51 patients with Stage IV disease across Phase 1a and 1b, with a median follow-up of 28.8 months. The Phase 1b safety population of 22 patients was heavily pretreated: 82% had received two or more prior TKIs and 41% had received prior belzutifan. Median time from enrollment to therapy start was four days, a logistical advantage inherent to the off-the-shelf format.
Safety in Phase 1b was more manageable than Phase 1a. The three Grade 5 treatment-related adverse events all occurred in Phase 1a; Phase 1b recorded none. Cytokine release syndrome appeared in 68% of Phase 1b patients but produced zero Grade 3 or higher events. IEC-HS, the immune effector cell-associated HLH-like syndrome that allogeneic platforms can trigger, occurred in 36% but was mostly mild to moderate and controlled through a protocol-defined management algorithm. The hematologic toxicity profile, dominated by neutropenia and thrombocytopenia, reflects lymphodepletion rather than unique ALLO-316 pathology. Critically, no graft-versus-host disease was observed, the safety concern that has historically shadowed allogeneic cell therapies. The RCC treatment landscape after checkpoint inhibitor and TKI combinations have failed remains punishing for patients, with survival often measured in months, which makes the unreached median overall survival in the CD70-high cohort genuinely striking.
The immediate clinical marker to track is whether Allogene’s Phase 2 regimen holds the 31% response rate and the durability signal in a larger, prospectively enriched CD70-high population. If responses begin maturing and the mDOR sets a floor above the 6.9-month lower confidence bound, ALLO-316 transitions from a proof-of-concept result into a registration-enabling dataset.
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.
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