eligibility_summary
Inclusion: life expectancy ≥3 mo, ECOG 0–1, advanced solid tumors (melanoma, cervical/ovarian, HNSCC, NSCLC, esophageal, others) after failing/no standard therapy, tissue for TILs (resection >1.5 cm³ or biopsy ≥6 lesions), ≥1 measurable lesion after collection, adequate organ function. Exclusion: other malignancy ≤5 yrs (some cured allowed), systemic/local anticancer or investigational therapy <4 wks (limited RT exceptions), unresolved >G1 AEs (except alopecia, irreversible neurotox, chronic G2 hypothyroidism), prior allogeneic HSCT/solid transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Early-phase, single-arm study of LM103 in advanced solid tumors. Interventions/mechanisms: • LM103 (autologous tumor-infiltrating lymphocytes, cellular immunotherapy). Patient tumor is resected, TILs are expanded/activated ex vivo and reinfused (≥5×10^9 cells). Mechanism: TCR-mediated recognition of tumor antigens/neoantigens, cytotoxic killing via perforin/granzyme and IFN-γ. • Lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog antimetabolite) to reduce endogenous lymphocytes/Tregs, create “space,” and boost homeostatic cytokines (IL-7/IL-15), enhancing TIL engraftment and function. • IL-2 (cytokine therapy) post-infusion to promote T-cell proliferation/survival via IL-2R/JAK-STAT signaling. Targets: Tumor cells expressing patient-specific antigens, immune pathways include TCR signaling, IL-2 signaling, depletion of Tregs/competing lymphocytes to optimize TIL activity.