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

• Status: Active, not recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 dose escalation study following a 3+3 study design. 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, and ALLO-647 to define a Phase 2 dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allogene Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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.

• Patients unwilling to participate in the extended safety monitoring period.