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

Study acronym: BAH2573-104
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Essen Biotech
17 trials monitored
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Ovarian Cancer
1,336 trials monitored
See 90 trials at risk
Sarcoma
1,026 trials monitored
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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
(from sponsor)		 Ovarian Cancer, Ovarian Carcinoma, Ovarian Sarcoma, Ovarian Cancer Stage IV
Related terms Ovarian Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov