NCT04696731

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Allogene Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, with or without ALLO-647 to define a Phase 2 dose.

Conditions

• Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
GENETIC	ALLO-316	ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
BIOLOGICAL	ALLO-647	ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
DRUG	Fludarabine	Chemotherapy for lymphodepletion
DRUG	Cyclophosphamide	Chemotherapy for lymphodepletion

Timeline

• Start date: 2021-02-24
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2021-01-06
• Last updated: 2025-09-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study