eligibility_summary
Adults (≥18) with histologically/cytologically confirmed malignant solid tumors and ≥1 measurable lesion who can provide a fresh biopsy for vaccine prep and have developed secondary resistance after PD‑1/PD‑L1 therapy (e.g., MSI‑H GI cancers). Exclusions: allergy to tumor vaccines/Sintilimab or severe mAb reactions, predicted neoantigens <10, pregnant/breastfeeding, or life expectancy <3 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05949775. Intervention: a personalized neoantigen mRNA cancer vaccine (biological, mRNA vaccine) combined with sintilimab (anti–PD-1 monoclonal antibody, IgG4, immune checkpoint inhibitor). Mechanisms: the mRNA vaccine encodes patient-specific tumor neoantigens, after uptake by antigen‑presenting cells (especially dendritic cells), antigens are translated and presented on MHC I/II to prime/expand tumor‑specific CD8+ cytotoxic and CD4+ helper T cells, broadening the TCR repertoire. Sintilimab blocks the PD‑1/PD‑L1 checkpoint to reverse T‑cell exhaustion and sustain effector function. Targeted cells/pathways: dendritic cells/APCs, CD8+ and CD4+ T cells, PD‑1 on T cells and PD‑L1 in the tumor microenvironment, antigen presentation (MHC I/II) and T‑cell activation pathways. Population: advanced solid tumors with secondary resistance to PD‑1/PD‑L1 therapy.