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Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Sponsor: Essen Biotech
Summary
This is a multicenter, open-label Phase 1/2 clinical trial evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. Eligible patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of autologous CD146-directed CAR-T cells (Arm A) and a subsequent infusion of autologous GPC3-directed CAR-T cells (Arm B). The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.
Official title: Phase 1/2 Study of Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Key Details
Gender
All
Age Range
21 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-04-29
Completion Date
2029-12-28
Last Updated
2025-07-16
Healthy Volunteers
No
Interventions
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.
Locations (1)
District One Hospital
Beijing, Beijing Municipality, China