Study Details

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Phase I Study of Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3 T c

The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3 T cells) in patients with glioblastoma. These cells have not been tested in humans. This treatment has not been approved by the Food and Drug Administration. This treatment may or may not benefit your type of cancer. However, the information collected from your participation would help cancer patients in the future. The study team wants to know how much (dose) of the CAR.B7-H3 T cells is safe to use in patients without causing too many side effects and, if they are, what is the maximum dose that could be tolerated.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

After a consultation with the study team your blood will be collected so the manufacturing process to make the modified study treatment cells can begin. The modified study cells will hopefully be more effective at killing your cancer cells than your body's normal cells. The study team will do blood tests and other procedures to confirm it is safe for you to get the modified study cells. If you are eligible, you will complete three to four days of pre-treatment that will prepare your body to accept the study cells better. You will then receive the study cell infusion. You will receive up to 3 infusions of the CAR.B7-H3 T cells. You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow-up assessments that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment

In-person visits:
Variable - based on disease and side effects

Phone or online visits:
Variable - based on worsened disease

Total length of participation:
Up to 5 years - this includes treatment, short-term follow up, and long-term follow up

Looking for Specific Volunteers

Able to participate:

Diagnosis of recurrent glioblastoma in the parts of the brain called the cerebrum or cerebellum; resection or boipsy of the tumor required at initial diagnosis
Undergone a sufficient level of radiation (at least 4005 cGy) in conjunction with temozolomide treatment
Disease that is able to have response to treatment evaluated (measurable disease)
Willingness to comply with study requirements (stay close to UNC after infusion, have intraventricular catheter placed (Ommaya reservoir), biopsy, etc.),
Adequate performance status (ability to perform daily tasks) and organ function, based on specified laboratory results/parameters

Not eligible if:

Cannot undergo an MRI, whether related to a reaction to the contrast agent used or because of surgically implanted materials that are not MRI safe
Active infection with HIV, HTLV, Hepatitis B or Hepatitis C
Evidence of disease in the brainstem, cerebellum, or spinal cord
Current or previous treatments that target development of new blood vessels, like bevacizumab; current use of corticosteroids at daily doses of 2 mg or dexamethasone
Washout exclusions related to prior treatments

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yasmeen Rauf
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Brain and Other Nervous System, Phase 1 Trials (all cancers))

IRB Number

21-0658

ClinicalTrials.gov

NCT05366179