Clinical Trial

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

Study acronym: BAH2573-104
Recruiting Phase 1/2
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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.
Trial Details
NCT Number NCT07067255
Lead Sponsor Essen Biotech
Conditions Ovarian Cancer, Ovarian Carcinoma, Ovarian Sarcoma, Ovarian Cancer Stage IV
Enrollment 80 participants
Start Date 2025-04-29
Primary Completion 2028-12-10 (estimated)
Study Completion 2029-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-07-16