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

NCT04696731 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Allogene Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696731 on ClinicalTrials.gov