Status:
RECRUITING
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 treat...
Detailed Description
This is a phase 1, single center, open-label study aims to determine the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells targeting the B7-H3 antigen administered via intr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Karnofsky score of \> 60%
- Diagnosis or recurrent supratentorial- or infra-tentorial glioblastoma multiforme (GBM) (World Health Organization 2016 or 2021) based on Response assessment in neuro-oncology criteria (RANO) magnetic resonance imaging (MRI) criteria. Disseminated GBM down the spinal cord is not allowed. Must have previously undergone resection or biopsy at initial diagnosis.
- Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
- No current or previous exposure to antiangiogenic agents, such as bevacizumab.
- Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation.
- Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the cell infusion therapy. If a male subject receives multiple infusions, they must remain on contraception throughout the duration and 3 months after the last cell infusion therapy.
- The subject is willing and able to comply with study procedures based on the judgment of the investigator.
- EXCLUSION CRITERIA
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
- Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Active infection with HIV, hepatitis B virus, hepatitis C virus (HCV). Note: To meet eligibility subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies, negative for Hepatitis B surface antigen, and negative for HCV antibody and viral load.
- Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.
- Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
- Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.
- Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.
Exclusion
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05366179
Start Date
September 2 2022
End Date
May 30 2030
Last Update
October 20 2025
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599