OncRef

Clinical Trial: NCT04696731

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Allogene Therapeutics
Information Provided By:Allogene Therapeutics
Last Update Posted:2026-08-27

Study Overview

Brief Summary

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.

Official Title

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)

Conditions

Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Intervention / Treatment

  • Genetic: ALLO-316
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Other Study ID Numbers

  • ALLO-316-101

Start Date (Actual)

2021-02-24

Primary Completion Date (Estimated)

2030-01

Study Completion Date (Estimated)

2030-01

Enrollment (Estimated)

120

Study Type

Interventional

Phase

Phase 1