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

Running, not enrolling · Phase 1

Conditions studied: Advanced/Metastatic Clear Cell Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04696731

Run by

Allogene Therapeutics

People needed

120

Starts

2021-02-24

Expected to finish

2030-01-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.