Clinical Trial

Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas

Study acronym: BAH2573-103
Recruiting Phase 1/2
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Summary
This is an open-label, non-randomized, multicenter Phase 1/2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.
Trial Details
NCT Number NCT07066982
Lead Sponsor Essen Biotech
Conditions Sarcoma, Sarcoma, Kaposi, Sarcoma, Ewing, Sarcoma,Soft Tissue, Sarcoma of Bone and Connective Tissue, Sarcoma, Synovial, Sarcoma Metastatic, Sarcomas, Germinoblastic +1 more
Enrollment 60 participants
Start Date 2025-05-29
Primary Completion 2027-12-10 (estimated)
Study Completion 2028-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-07-15