Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 2, 2022

Primary Completion Date

May 30, 2030

Study Completion Date

May 30, 2030

Conditions
Glioblastoma Multiforme
Interventions
DRUG

CAR.B7-H3T cells infusion

"The Chimeric Antigen Receptors (CAR).B7-H3T cells will be administered via intraventricular infusion up to 3 weekly infusions. A suspension of T cells infusion is given, over 5-10 minutes, via a Rickham catheter and will be followed by a normal-saline flush.~Dose escalation will be performed considering the dose limiting toxicities (DLTs) listed in the protocol. Six doses will be explored. The starting dose will be 2 × 10\^6 transduced cells/infusion (Dose Level (DL) 1) and will enroll at least 3 subjects. If there are no dose DLTs within 4 weeks of the third cellular product administration in the first 3 subjects, then the next cohort will evaluate 5 × 10\^6 transduced cells/infusion (DL2)."

Trial Locations (1)

27599

RECRUITING

Lineberger Comprehensive Cancer Center, Chapel Hill

All Listed Sponsors
lead

UNC Lineberger Comprehensive Cancer Center

OTHER