ALLO-316 - (TRAVERSE)

July 15, 2026: Allogene Therapeutics, Inc. (NASDAQ: ALLO) announced publication in the Journal of Clinical Oncology of complete Phase 1 data from the ongoing TRAVERSE study of ALLO-316, a CD70-targeting allogeneic CAR T therapy using its Dagger® technology, in advanced/metastatic clear cell renal cell carcinoma (RCC) conducted in collaboration with MD Anderson.

Across Phase 1, 51 Stage IV patients enrolled; 46 received ALLO-316 (median follow-up 28.8 months). The Phase 1b expansion cohort tested the recommended Phase 2 regimen: 80M CAR T cells after standard fludarabine/cyclophosphamide lymphodepletion. In Phase 1b, patients were heavily pretreated (checkpoint inhibitor- and TKI-resistant; 41% previously received belzutifan). Median time from enrollment to therapy start was 4 days.

Efficacy (Phase 1b): confirmed ORR was 25% (5/20) overall and 31% (5/16) in CD70-high tumors (TPS ≥50%); 0/4 responses in TPS <50%. Median DOR was not reached (95% CI 6.9 months to not estimable) with responses 8 to 18+ months; all responders in the CD70-high cohort were progression-free at analysis. Median OS was 15.2 months overall and not estimable in CD70-high patients.

Safety: manageable; most common grade ≥3 events were hematologic. Three treatment-related grade 5 events occurred in Phase 1a; none in Phase 1b. IEC-HS occurred in 36% (grade ≥3: 9%) and was managed per protocol; CRS occurred in 68% with no grade ≥3; ICANS 18% (no grade ≥3).

Regulatory: FDA granted RMAT designation (Oct 2024) and Fast Track designation (Mar 2023) for ALLO-316 in advanced/metastatic RCC.