NCT05366179 Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
| NCT ID | NCT05366179 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Glioblastoma Multiforme |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-09-02 |
| Primary Completion | 2030-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2022-09-02 with a primary completion date of 2030-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.
Eligibility Criteria
INCLUSION CRITERIA 1. Karnofsky score of \> 60% 2. 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. 3. Must have undergone at least 4005 cGy of radiation with concurrent temozolomide. 4. No current or previous exposure to antiangiogenic agents, such as bevacizumab. 5. 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. 6. 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. 7. The subject is willing and able to comply with study procedures based on the judgment of the investigator. EXCLUSION CRITERIA 1. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study). 2. 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. 3. 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. 4. Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials. 5. Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma. 6. Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord. 7. Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.
Contact & Investigator
Felicia Cao, MD, PhD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05366179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05366179 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05366179 currently recruiting?
Yes, NCT05366179 is actively recruiting participants. Contact the research team at UNCImmunotherapy@med.unc.edu for enrollment information.
Where is the NCT05366179 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05366179 clinical trial?
NCT05366179 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Felicia Cao, MD, PhD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 36 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.