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CAR T-cell Therapy

CAR-T Cell Therapy for Glioblastoma

Phase 1

Recruiting

Led By Yasmeen Rauf, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

No current or previous exposure to antiangiogenic agents, such as bevacizumab.

Karnofsky score of > 60%

Must not have

Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.

Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if it's safe to use CAR.B7-H3T cells, a treatment for glioblastoma that hasn't been tested on humans before.

Who is the study for?

This trial is for adults with recurrent glioblastoma who've had radiation and temozolomide treatment, but no antiangiogenic agents like bevacizumab. They must not have widespread disease down the spinal cord or previous CAR-T therapy, and should be able to follow study procedures. Women of childbearing age and men with partners must agree to use contraception.

What is being tested?

The trial is testing a new potential treatment called CAR.B7-H3T cells infusion for glioblastoma patients. This involves modifying T cells to target cancer cells more effectively. It's an early-stage trial focusing on safety since this approach hasn't been tried in humans before.

What are the potential side effects?

Since this is the first time CAR.B7-H3T cell infusion is being tested in humans, specific side effects are unknown but may include immune reactions, fever, fatigue, headache, or other symptoms related to changes in blood counts or immune system activity.

Eligibility Criteria

Inclusion Criteria

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

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I have never been treated with drugs that stop the formation of blood vessels in cancer.

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I am able to care for myself but may not be able to do active work.

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I have a recurring brain tumor (GBM) not spread to the spinal cord, confirmed by MRI.

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I have completed radiation therapy with a specific drug.

Exclusion Criteria

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

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My cancer has spread to my brainstem, cerebellum, or spinal cord.

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I have had carmustine wafers or brachytherapy for my brain tumor.

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I have had CAR T-cell therapy for my brain cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Syndrome

Neurotoxicity

Number of participants with adverse event

Secondary study objectives

Duration of Response (DOR)

Identification of Recommended phase 2 dose (RP2D)

Objective Response Rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

CAR.B7-H3 T cells: Subjects with refractory or recurrent glioblastoma multiforme, have cells collected following their initial surgical resection to manufacture CAR.B7-H3 T cells, preferably before initiation of adjuvant chemoradiation.

0 / 7Eligibility criteria met