eligibility_summary
Eligibility: Advanced solid tumors (e.g., melanoma, HNSCC, soft tissue sarcoma) with no suitable standard therapy, ECOG 0–1, survival ≥6 mo, adequate organs, tumor for TIL harvest (resection >1.5 cm3 or ≥6 biopsies), ≥1 measurable lesion (RECIST 1.1). Exclude: other malignancy <5 yrs (cured exceptions), anticancer/investigational therapy within 4 wks, unresolved >G1 AEs (except alopecia, irreparable neurotoxicity, chronic G2 hypothyroidism), prior allogeneic HSCT or solid organ transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05971589 tests LM103, an autologous tumor-infiltrating lymphocyte (TIL) adoptive cell therapy for advanced solid tumors. Intervention components: 1) LM103 (biological cell therapy): ex vivo–expanded patient CD8+/CD4+ TILs reinfused to mediate TCR-dependent recognition and cytotoxic killing of tumor antigen–bearing cells. 2) Lymphodepletion with cyclophosphamide (alkylating chemotherapy) and fludarabine (purine analog) to deplete endogenous lymphocytes/Tregs, reduce cytokine sinks, and promote TIL engraftment. 3) Interleukin-2 (cytokine immunotherapy) to expand/sustain infused T cells via IL-2R–JAK/STAT5 signaling. Targets/pathways: tumor antigen–specific T cells in the tumor microenvironment, TCR-mediated cytotoxicity, IL-2 signaling, and reduction of immunosuppressive Tregs.