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

A Phase 1A/1B Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 With Cyclophosphamide/Fludarabine Lymphodepletion Alone or Including ALLO-647 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

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.