eligibility_summary
Adults 18–75, ECOG 0–1, >3‑mo survival, measurable disease, adequate marrow/organ/coagulation, tumor tissue available and vaccine neoantigen positive. Part 1: advanced solid tumors after standard failure. Part 2 (NSCLC): tx‑naive PD‑L1≥1%, post‑standard progression (any PD‑L1) for ICI mono, or stage II–III post‑op adjuvant PD‑L1≥1%. Exclude: unstable illness, major cardiac/QTc/LVEF issues, active brain mets, HBV/HCV/HIV, autoimmune (limited allowed), pregnancy, recent surgery/therapy, transplants, immunosuppression, hypersensitivity, prior severe ICI AEs (Part 2), unresolved ≥G2 AEs, recent 2nd malignancy, malignant effusions, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Early-phase, single-center study testing JCXH-212, a community-type tumor neoantigen mRNA vaccine, alone and with toripalimab in malignant solid tumors. JCXH-212 induces active immunity by generating tumor-specific CD4+ and CD8+ T cells that recognize and kill cancer cells. Toripalimab is an anti–PD-1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-1 signaling to restore T-cell antitumor function. Targets: T lymphocytes (CD4+, CD8+), neoantigen-specific immune responses, and the PD-1/PD-L1 checkpoint pathway within the tumor microenvironment. Primary aim: evaluate safety/tolerability, dose-limiting toxicities, and maximum tolerated dose.