eligibility_summary
Eligible: ≥16, biopsy‑proven R/R extremity osteosarcoma post CSCO 1L failure/intolerance, not surgery candidates, measurable disease, GPC3+ IHC (tissue ≤2y, CD40 tested), KPS≥60, survival ≥12 wks, adequate labs/organ function, consent. Exclude: brain mets, recent local tx/surgery/IO/steroids, autoimmune on immunosuppression, prior GPC3‑targeted or cell therapy, serious CNS/pulmonary/cardiac disease, active HBV/HCV/HIV/syphilis/EBV/CMV, anticoagulants/antiplatelets, recent DVT/PE, uncontrolled infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-center, single-arm, dose-escalation trial of IM83 CAR-T for relapsed/refractory osteosarcoma. Intervention: IM83 CAR-T cells (autologous chimeric antigen receptor T cells) infused once after lymphodepleting chemotherapy with fludarabine 30 mg/m^2 and cyclophosphamide 300 mg/m^2 (days −5 to −3), doses: 5×10^8, 1×10^9, or 2×10^9 cells. Mechanism: patient T cells are engineered to express a CAR targeting glypican‑3 (GPC3), enabling MHC‑independent recognition and killing of GPC3-positive tumor cells via T-cell activation, cytokine release, and cytotoxic pathways, trial requires GPC3 IHC positivity. Lymphodepletion (fludarabine, a purine analog, cyclophosphamide, an alkylating agent) reduces host lymphocytes to enhance CAR-T expansion/persistence. CD40 is assessed by IHC but is not a treatment target. Targets: GPC3+ osteosarcoma cells and T-cell activation pathways.