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

Introduction

• Org Study ID: ALLO-316-101
• NTC ID: NCT04696731
• Lead Sponsor Name: Allogene Therapeutics
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief 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.

Eligibility 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.