NCT05366179RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 4 May 2022
- Start date
- 2 Sept 2022
- Primary completion date
- 30 May 2030
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Glioblastoma
- NCT number
- NCT05366179
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 2 Sept 2022 to the primary completion date, 30 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
- Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.
Other illness
- 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.
- Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.
Other
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
- Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.