eligibility_summary
Eligibility: Adults 18–70 with GI/GU, breast/ovarian, NSCLC, or glioblastoma, measurable disease and a resectable lesion for TIL, metastases required for 1–3. Prior standard therapy failed/declined. ECOG 0–1 (1–3) or KPS ≥60 (4), cohort 3 FEV1 >60%. Adequate labs, HIV/HBV/HCV neg, contraception, protocol washouts, limited brain mets allowed (1–3). Exclude: pregnancy, steroids (except 4), active infection, immunodeficiency, cardiopulmonary disease, hypersensitivity, recent CNS bleed (4), other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT04102436 (withdrawn): Phase II, single-arm adoptive cell therapy. Interventions: 1) Sleeping Beauty–transposed autologous peripheral blood T cells (cellular gene therapy, non-viral integrating transposon/transposase) engineered to express patient-specific TCRs against mutated neoantigens, mechanism: TCR–HLA recognition of tumor neoantigens leading to targeted cytotoxicity. 2) Cyclophosphamide (alkylating agent) and 3) Fludarabine (purine analog) for non-myeloablative lymphodepletion to improve T-cell engraftment and homeostatic cytokines. 4) Aldesleukin/IL-2 (cytokine immunotherapy) to expand/activate transferred T cells. Targets: tumor cells bearing unique mutated neoantigens, pathways: antigen processing/presentation (HLA), TCR signaling, and IL-2–driven T-cell proliferation. Withdrawn due to lack of GLP-grade reagents.