eligibility_summary
Include: Advanced/metastatic breast, colorectal, uveal or cutaneous melanoma, NSCLC, or HNSCC refractory to standard care, ≥1 measurable lesion and tumor for TIL harvest, ECOG 0–1, adequate organs. Exclude: other active cancer <3y, immunodeficiency/immunosuppression, active HIV/HBV/HCV/syphilis/WNV/HTLV/CMV, active CNS mets, serious cardiac disease (clearance if >60), prior cell/organ transplant, severe drug allergy, LVEF ≤45%, FEV1 ≤60% or DLCO <60%, fixed anticoagulation. Additional criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1b (terminated) study of: 1) TBio-4101—biological autologous adoptive cell therapy using neoantigen-selected, tumor-reactive tumor-infiltrating lymphocytes (TILs) expanded ex vivo, given after non-myeloablative lymphodepleting chemotherapy (cyclophosphamide, fludarabine) and low-dose radiation, with IL-2 support, and 2) pembrolizumab—drug, monoclonal antibody PD-1 checkpoint inhibitor, started after IL-2 toxicities resolve. Targets/pathways: patient’s tumor-specific CD8+/CD4+ T cells recognizing neoantigens via TCR/MHC, PD‑1/PD‑L1 checkpoint to reverse T-cell inhibition, IL‑2 receptor signaling to expand/activate T cells, lymphodepletion to reduce competing/suppressive lymphocytes and aid TIL engraftment. Tumors: breast, colorectal, uveal/cutaneous melanoma, NSCLC, HNSCC.