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CAR T-cell Therapy

ALLO-316 for Kidney Cancer (TRAVERSE Trial)

Phase 1
Recruiting
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 days
Awards & highlights

TRAVERSE Trial Summary

This trial is testing a new cancer treatment in people with advanced kidney cancer. The treatment will be given after a regimen to weaken the immune system. The goal is to find the safe dose for the treatment.

Who is the study for?
This trial is for adults with advanced kidney cancer (clear cell renal cell carcinoma) who have already tried certain other cancer treatments. Participants need to be relatively healthy and active, without serious brain metastases or CNS issues, no recent anti-CD70 or anti-CD52 therapies, and no other cancers in the last 3 years.Check my eligibility
What is being tested?
The TRAVERSE study is testing ALLO-316's safety and effectiveness after a treatment that reduces immune cells (lymphodepletion) using Fludarabine, Cyclophosphamide, and ALLO-647. It's an early-phase trial to find the right dose for Phase 2.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system suppression from lymphodepletion drugs like Fludarabine and Cyclophosphamide such as infections, low blood counts; also potential infusion-related reactions from ALLO-316.

TRAVERSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer is mainly made up of clear cells.
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I have been treated with drugs targeting the immune system and blood vessel growth for my advanced cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood, kidney, liver, lung, and heart functions are all within normal ranges.

TRAVERSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316

TRAVERSE Trial Design

1Treatment groups
Experimental Treatment
Group I: ALLO-647, ALLO-316Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Allogene TherapeuticsLead Sponsor
5 Previous Clinical Trials
572 Total Patients Enrolled

Media Library

ALLO-316 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04696731 — Phase 1
Renal Cell Carcinoma Clinical Trial 2023: ALLO-316 Highlights & Side Effects. Trial Name: NCT04696731 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What negative effects can result from the administration of ALLO-316?

"Our team at Power gave ALLO-316 a rating of 1, as this is merely a Phase 1 trial. Thus far there are just minimal evidence and studies to support the drug's safety and effectiveness."

Answered by AI

Could I potentially qualify to participate in this experiment?

"This research initiative is open to 120 patients aged between 18 and 75 who are suffering from renal cell carcinoma. Furthermore, the individual must have a minimum of one visible lesion as outlined in RECIST version 1.1 and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1."

Answered by AI

Is the eligibility for this research restricted to those under 35?

"To be in compliance with the trial's criteria, participants must be 18 or older and not exceed 75 years of age."

Answered by AI

Are there any precedential studies which have explored the potential of ALLO-316?

"Presently, 889 studies are underway for ALLO-316; of those active trials, 161 are in Phase 3. The epicentre is Philadelphia, PA but research sites span 28446 different locations around the globe."

Answered by AI

Is this research project welcoming more participants?

"As indicated on clinicaltrials.gov, this research effort is currently open for enrollment and was initially posted in February 2021 with a recent edit in March 2022."

Answered by AI

In what capacity is ALLO-316 typically employed?

"ALLO-316 is a popular drug used to treat multiple sclerosis, as well as mixed cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

In what geographic regions is this research endeavor being administered?

"Right now, there are 6 sites participating in this trial. These locations include Houston, Duarte and Portland as well as 3 other cities. To make the process more convenient for participants, it is recommended to enroll at the site nearest them."

Answered by AI

How many individuals are currently participating in this experiment?

"In order for this trial to attain the necessary data, 120 qualified candidates need to volunteer. Those wishing to participate can do so at either MD Anderson Cancer Center in Houston or City of Hope in Duarte."

Answered by AI
~34 spots leftby Aug 2025