Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 29, 2025

Primary Completion Date

December 10, 2028

Study Completion Date

December 28, 2029

Conditions
Ovarian CancerOvarian CarcinomaOvarian SarcomaOvarian Cancer Stage IV
Interventions
BIOLOGICAL

GPC3 CD146 CAR-T cells

"The intervention in this clinical trial involves a novel approach using CD146/GPC3 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.~Treatment Regimen:~Patients in the trial will undergo the following regimen:~Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.~Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.~GPC3/CD146 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, GPC3/CD146 CAR T cells, over 10-20 minutes on day 0.~Additional Doses: Eligible patients responding well to the initial CD146/GPC3 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses."

Trial Locations (1)

086-373

RECRUITING

District One Hospital, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Essen Biotech

OTHER