Using CAR-T cells to target B7-H3 in recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial aims to evaluate the safety of CAR-T cell therapy targeting the B7-H3 antigen in patients with recurrent or refractory glioblastoma multiforme (GBM). Participants will undergo a procedure to collect their T cells, which will then be modified to create CAR.B7-H3T cells. These modified cells will be infused into patients via intraventricular infusion, with up to three weekly doses administered. The study will also determine the maximum tolerated dose and the recommended dose for future studies based on safety and feasibility.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Felicia Cao, MD, PhD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Catherine Cheng
• Email: UNCImmunotherapy@med.unc.edu
• Phone: 919-445-4208

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• Natalizumab to help prevent brain-related side effects during CAR-T therapy in certain lymphoma patients

  This phase 2 study tests whether natalizumab can reduce severe ICANS in adults with recurrent or refractory DLBCL or MCL receiving CAR-T therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07892027

• CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

  This study tests whether a patient’s own CD19 CAR-T cells can help children and young adults with severe, hard-to-treat lupus.

  Recruiting Phase 1 Seoul National University Hospital · Seoul · NCT07855302

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CAR-T Cell Therapy for B-ALL (relapsed/refractory)

  This trial tests a patient’s own CAR-T cells to treat relapsed or refractory B-cell ALL in people aged 5–50.

  Recruiting Early Phase 1 National Institute of Blood and Marrow Transplant (NIBMT), Pakistan · Rawalpindi · NCT07695012

• Bendamustine vs standard lymphodepletion before CAR-T in LBCL

  This trial tests whether bendamustine can replace the standard bendamustine-free lymphodepletion before CAR-T therapy in adults with large B-cell lymphoma who have had prior treatment.

  Recruiting at 8 sites Phase 2 Swiss Cancer Institute · Aarau and 8 other locations · NCT07593482

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.