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

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 (ch

Trial Details

NCT ID
NCT07066982
Phase
PHASE1 / PHASE2
Sponsor
Essen Biotech
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • CD146/HER2 CAR-T cells
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Expected survival time ≥3 months;
  • Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to …
  • Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on numb…
  • Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consen…

For full eligibility, visit ClinicalTrials.gov.

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