Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

January 27, 2021

Primary Completion Date

December 19, 2024

Study Completion Date

February 28, 2030

Conditions
Epithelial Ovarian Cancer
Interventions
DRUG

CAR.B7-H3

Two dose levels will be evaluated: Dose Level 1 (7.5x10\^7 cells/infusion), dose Level 2 (2x10\^8 cells/infusion). If dose limiting toxicities (DLTs) are observed per protocol, Dose Level -1 (3.75x10\^6 cells/infusion) will be evaluated.

DRUG

Fludarabine

30 mg/m\^2 IV for 3 consecutive days

DRUG

Cyclophosphamide

300 mg/m\^2 IV for 3 consecutive days

Trial Locations (1)

27599

Lineberger Comprehensive Cancer Center, Chapel Hill

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER