Allogeneic CD70-Targeted Chimeric Antigen Receptor T-Cell Therapy for Advanced Renal Cell Carcinoma: Results From the Phase I TRAVERSE Trial.
Publication Title
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Document Type
Article
Publication Date
8-20-2026
Keywords
Humans; Carcinoma, Renal Cell; Female; CD27 Ligand; Middle Aged; Male; Kidney Neoplasms; Receptors, Chimeric Antigen; Aged; Adult; Immunotherapy, Adoptive; T-Lymphocytes; oregon; portland
Abstract
PURPOSE: Treatment options for clear cell renal cell carcinoma (ccRCC) refractory to immune checkpoint inhibitors (ICIs) and targeted therapy are needed. ALLO-316 is an allogeneic chimeric antigen receptor (CAR) T-cell product that targets CD70-expressing ccRCC and resists immune rejection by targeting and eliminating patients' CD70
METHODS: In the phase Ia/b TRAVERSE trial (ClinicalTrials.gov identifier: NCT04696731), patients with advanced ccRCC resistant to ICIs and vascular endothelial growth factor receptor-targeted therapy received lymphodepletion and ALLO-316 following a modified 3 + 3 design. Phase Ia evaluated ALLO-316 dose and fludarabine/cyclophosphamide (FC)-based lymphodepletion with/without the anti-CD52 antibody, ALLO-647. Additional patients were enrolled in phase Ib to confirm the expansion regimen identified in phase Ia. Primary end points were dose-limiting toxicities (DLTs) and adverse events (AEs).
RESULTS: Fifty-one patients were enrolled (phase Ib, n = 23). Patients received a median of four prior lines of therapy. The median follow-up was 28.8 months. DLTs occurred in two patients who received ALLO-647 (grade 3 autoimmune hepatitis; grade 5 cardiogenic shock). Grade ≥3 cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome occurred in 2.0%, 0%, and 6.0% of patients, respectively. Most grade ≥3 AEs were hematologic (neutropenia 62.0%; white blood cell count decreased 54.0%; anemia 36.0%). In phase Ib, patients received FC and 80 × 10
CONCLUSION: ALLO-316 had manageable safety and encouraging antitumor activity in CD70-positive ccRCC. The TRAVERSE trial demonstrates proof of concept for the role of allogeneic CAR T-cell therapy in solid tumors.
Area of Special Interest
Cancer
Area of Special Interest
Kidney & Diabetes
Specialty/Research Institute
Nephrology
Specialty/Research Institute
Oncology
Specialty/Research Institute
Surgery
DOI
10.1200/JCO-26-00388
