eligibility_summary
Inclusion: Adults 18–75 with advanced, measurable solid tumors (e.g., melanoma, driver mutation–negative NSCLC), HLA-A02:01/A11:01/A24:02, failed/intolerant to standard care, ECOG 0–1, life expectancy >6 mo, adequate labs/organ function (HIV/HBV/HCV−, coag ≤1.5×ULN, LVEF ≥50%), ≥4 wks since last therapy, venous access, consent, contraception, biopsy/resectable lesion. Exclusion: pregnancy, transplant, brain mets, major autoimmune/infection, severe organ/CV/ILD/HTN, recent steroids/immunomodulators, other recent cancers, antigen-presentation defects, hypersensitivity, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1, single-arm study of Neo-T (autologous neoantigen-targeted T cell therapy) combined with an anti–PD-1 antibody (toripalimab for melanoma or tislelizumab for NSCLC/others). Neo-T: ex vivo expanded patient PBMC-derived cytotoxic T cells (primarily CD8+) specific to personalized tumor neoantigens, HLA-A02:01/A11:01/A24:02–restricted, mechanism: TCR-mediated recognition of neoantigen–HLA I on tumor cells and killing via perforin/granzyme. Toripalimab and tislelizumab: IgG4 monoclonal antibodies blocking PD-1 to restore and sustain T-cell activity, reducing exhaustion, tislelizumab has engineered Fc to minimize FcγR binding. Targets/pathways: tumor cells presenting neoantigens via HLA class I, TCR signaling, cytotoxic effector pathways, PD-1/PD-L1 immune checkpoint in the tumor microenvironment. Aim: safety and preliminary efficacy in advanced solid tumors.