Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05366179

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-22

36

Participants Needed

1

Research Sites

403 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Karnofsky score greater than 60%
  • Diagnosis of recurrent supratentorial or infratentorial glioblastoma multiforme based on MRI criteria
  • Previous resection or biopsy at initial diagnosis
  • Completed at least 4005 cGy of radiation with concurrent temozolomide
  • No prior or current treatment with antiangiogenic agents such as bevacizumab
  • Female participants of childbearing potential agree to use two effective contraception methods or abstain from heterosexual activity from consent until 6 months after study treatment
  • Male participants with female partners have had vasectomy or agree to use contraception from first dose until 3 months after last infusion
  • Willing and able to comply with study procedures as judged by the investigator
Not Eligible

You will not qualify if you...

  • Pregnant or lactating individuals
  • Prior or concurrent malignancies that may interfere with safety or efficacy assessments
  • Active infection with HIV, hepatitis B, hepatitis C, or HTLV1/2
  • Contraindication to MRI contrast agents or inability to undergo MRI due to incompatible implants
  • Previous treatment with chimeric antigen receptor T cell therapy for glioblastoma
  • Disseminated disease involving brainstem, cerebellum, or spinal cord
  • Previous implantation of carmustine wafers or brachytherapy for glioma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

C

Catherine Cheng

CONTACT

C

Caroline Babinec

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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