Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

This is a Phase 1 dose escalation study using a 3+3 study design, followed by a phase 1b expansion study. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, with or without ALLO-647 to define a Phase 2 dose.

Inclusion Criteria: * Histologically confirmed renal cell carcinoma with a predominant clear cell component. * Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting. * At least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. * Absence of donor (product)-specific anti-HLA antibodies (DSA). * Adequate hematological, renal, liver, pulmonary, and cardiac functions. Exclusion Criteria: * Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression. * Clinically significant CNS dysfunction. * Any other active malignancy within 3 years prior to enrollment. * Prior treatment with anti-CD70 therapies. * Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy. * Prior treatment with anti-CD52 monoclonal antibody in the past 12 months. * Participants unwilling to participate in the extended safety monitoring period.