RecruitingPhase 1NCT05366179

Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc

Phase I Study of Intraventricular Infusion of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) in Subjects With Recurrent or Refractory Glioblastoma


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

36 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cell therapy (CAR-T cells) for people with brain cancer called glioblastoma (GBM) that has come back after initial treatment. The therapy uses the patient's own immune cells, engineered to target a protein called B7-H3 found on GBM tumor cells. **You may be eligible if...** - You have been diagnosed with recurrent or treatment-resistant glioblastoma - You have previously had surgery or biopsy and received radiation with chemotherapy - You have not been treated with anti-angiogenic drugs like bevacizumab - You have not previously received CAR-T therapy for glioblastoma - You are well enough to function independently (Karnofsky score above 60%) - You are able to have an MRI scan **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have HIV, hepatitis B, or hepatitis C - You have another active cancer that may interfere with this study - Your brain tumor has spread to the brainstem, cerebellum, or spinal cord - You have metal implants or a pacemaker that prevents MRI - You have previously had carmustine wafers implanted in your brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCAR.B7-H3T cells infusion

The Chimeric Antigen Receptors (CAR).B7-H3T cells will be administered via intraventricular infusion up to 3 weekly infusions. A suspension of T cells infusion is given, over 5-10 minutes, via a Rickham catheter and will be followed by a normal-saline flush. Dose escalation will be performed considering the dose limiting toxicities (DLTs) listed in the protocol. Six doses will be explored. The starting dose will be 2 × 10\^6 transduced cells/infusion (Dose Level (DL) 1) and will enroll at least 3 subjects. If there are no dose DLTs within 4 weeks of the third cellular product administration in the first 3 subjects, then the next cohort will evaluate 5 × 10\^6 transduced cells/infusion (DL2).


Locations(1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT05366179


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