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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Syndrome
Neurotoxicity
Number of participants with adverse event
Secondary outcome measures
Duration of Response (DOR)
Identification of Recommended phase 2 dose (RP2D)
Objective Response Rate (ORR)
+2 more

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.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,437 Total Patients Enrolled
1 Trials studying Glioblastoma
10 Patients Enrolled for Glioblastoma
Yasmeen Rauf, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

CAR.B7-H3T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05366179 — Phase 1
Glioblastoma Research Study Groups: Single Arm
Glioblastoma Clinical Trial 2023: CAR.B7-H3T cells Highlights & Side Effects. Trial Name: NCT05366179 — Phase 1
CAR.B7-H3T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366179 — Phase 1
~6 spots leftby Oct 2024
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