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ACTIVE NOT RECRUITING Phase 1

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

NCT04696731 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • GENETIC ALLO-316
  • BIOLOGICAL ALLO-647

Study Locations (10)

California

  • City of Hope — Duarte
  • UCLA Medical Center — Los Angeles
  • UCSF Medical Center — San Francisco

Connecticut

  • Yale School of Medicine — New Haven

District of Columbia

  • Georgetown University Hospital — Washington D.C.

Florida

  • Moffitt Cancer Center — Tampa

Michigan

  • Karmanos Cancer Institute — Detroit

New York

  • Memorial Sloan Kettering Cancer Center — New York

Oregon

  • Providence Portland Medical Center — Portland

Texas

  • MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2021-02-24
Est. Completion 2025-12
Phase Phase 1

Sponsor

Allogene Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04696731

The ClinicalTrials.gov registry entry for NCT04696731 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allogene Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced/Metastatic Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04696731 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Connecticut, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04696731 about?

NCT04696731 is a clinical study titled "Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma". 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, cyclo...

What is the current status of trial NCT04696731?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2021-02-24. Estimated completion is 2025-12.

What conditions does trial NCT04696731 study?

This clinical trial studies the following conditions: Advanced/Metastatic Clear Cell Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04696731?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ALLO-316 (GENETIC), ALLO-647 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04696731?

This trial is sponsored by Allogene Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04696731 being conducted?

This trial has 10 study locations across California, Connecticut, District of Columbia, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial