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CAR T-cell Therapy

T-Cell Therapy for Glioblastoma

Phase 1

Waitlist Available

Led By Camilo Fadul, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histologically-confirmed newly diagnosed intracranial GBM or gliosarcoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of egfr bats

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving T-cells and standard care therapy. The purpose is to see if it is safe and effective.

Who is the study for?

Adults diagnosed with new intracranial glioblastoma or gliosarcoma, able to consent, with good organ function and blood counts. Women of childbearing age must test negative for pregnancy and agree to use contraception. Excludes those with certain heart conditions, HIV/Hepatitis B/C, recent vaccines, other cancers within 3 years (except some skin cancers), brain cancer spread outside the skull or in spinal fluid, known drug allergies.Check my eligibility

What is being tested?

The trial is testing EGFR Bi-armed Activated T-cells (BATs) combined with standard chemotherapy (temozolomide) and radiation therapy in patients with glioblastoma. The goal is to find a safe dose of EGFR BATs when used alongside these standard treatments.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune activation such as inflammation in various organs, infusion-related reactions from the T-cell therapy, and typical chemotherapy side effects like fatigue, nausea, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been newly diagnosed with a type of brain tumor called GBM or gliosarcoma.

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I can care for myself but may need occasional help.

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My kidney function is normal or near normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of egfr bats

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of egfr bats

This trial's timeline: 3 weeks for screening, Varies for treatment, and the study will not advance to the next dose until 7 days after the last patient in the cohort completes his or her second infusion of egfr bats for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose

Secondary outcome measures

Adverse events, including dose limiting toxicities

Clinical response

Correlation of clinical response to PFS and OS

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Subcohort for MGMT unmethylated patientsExperimental Treatment1 Intervention

Study participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. About 4 weeks after completion of RT/TMZ, participants will receive 8 weekly doses of EGFR BATs.

Group II: Main StudyExperimental Treatment1 Intervention

Study participants will have cells collected by leukapheresis prior to initiating standard concurrent RT and TMZ. Participants will receive the first and second infusions of EGFR BATs on days 14 and 21 after finishing concurrent RT and TMZ and then receive an infusion on day 21 of the first six cycles of TMZ.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

756 Previous Clinical Trials

1,245,288 Total Patients Enrolled

6 Trials studying Glioblastoma

191 Patients Enrolled for Glioblastoma

Camilo Fadul, MDPrincipal InvestigatorUniversity of Virginia

3 Previous Clinical Trials

7 Total Patients Enrolled

2 Trials studying Glioblastoma

4 Patients Enrolled for Glioblastoma

Media Library

EGFR BATs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03344250 — Phase 1

Frequently Asked Questions

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

Are there still opportunities to enroll in this research trial?

"According to the information on clinicaltrials.gov, this clinical trial has closed its enrollment process and is no longer searching for patients. Initially posted on March 1st 2018, it was last updated on May 13th 2022; however there are 442 other studies that continue to accept participants."

Answered by AI