← Back to Search

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

Must not have

There is clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA or ECHO results)

Patients with extracranial metastases

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

No Placebo-Only Group

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.

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.

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

Select...

I am 18 years old or older.

Select...

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

Select...

I can care for myself but may need occasional help.

Select...

My kidney function is normal or near normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am being treated for heart failure.

Select...

My cancer has spread outside of my brain.

Select...

I am currently experiencing or prone to frequent bleeding.

Select...

I have HIV, active Hepatitis B, or Hepatitis C.

Select...

I have received treatments other than surgery for my brain tumor.

Select...

I have not received a live vaccine in the last 30 days.

Select...

I am not currently breastfeeding.

Select...

I have heart issues, like angina or weak heart function (LVEF < 45%).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose

Secondary study objectives

Adverse events, including dose limiting toxicities

Clinical response

Correlation of clinical response to PFS and OS

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met