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ACTIVE NOT RECRUITING
NCT04696731
PHASE1

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

Sponsor: Allogene Therapeutics

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-02-24

Completion Date

2025-12

Last Updated

2025-09-25

Healthy Volunteers

No

Interventions

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

Locations (10)

City of Hope

Duarte, California, United States

UCLA Medical Center

Los Angeles, California, United States

UCSF Medical Center

San Francisco, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Moffitt Cancer Center

Tampa, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

MD Anderson Cancer Center

Houston, Texas, United States