eligibility_summary
Eligibility: >=12 yrs, advanced/metastatic soft-tissue or bone sarcoma (osteosarcoma expansion), evaluable disease, >=1 prior systemic therapy (unless none standard), standard washouts, ECOG 0-1, biopsy if feasible, adequate marrow/renal/hepatic/cardiac/pulmonary function, contraception. Exclude: cyclophosphamide allergy, active autoimmune, untreated/unstable CNS mets (stable treated allowed), concurrent cancer therapy, significant unresolved tox, immunodeficiency/transplant/TB, uncontrolled illness, pregnancy/lactation, HBV/HCV/HIV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05621668 (Phase 1). Interventions: attIL12‑T cells (adoptive T‑cell therapy engineered to express membrane‑anchored, tumor‑targeted interleukin‑12) plus cyclophosphamide (alkylating agent used for lymphodepletion), both IV. Mechanisms: attIL12 localizes IL‑12 signaling at the T‑cell/tumor interface to drive Th1 activation, enhance CD8+ T‑cell cytotoxicity and IFN‑γ production, and modulate the tumor microenvironment. Cyclophosphamide creates a permissive immune milieu for adoptive transfer and may reduce regulatory T cells to support expansion of infused T cells. Cells/pathways targeted or assessed: CD8+ effector T cells, FoxP3+ Tregs, CD33+ myeloid cells, IL‑12/IFN‑γ axis in tumor and blood, circulating cell‑surface‑vimentin (CSV)–positive CTCs. Indication: advanced/metastatic soft‑tissue and bone sarcomas, osteosarcoma expansion cohort.