Personalized Neoantigen-Pulsed Autologous Dendritic Cell Injections for Treating Malignant Solid Tumors with Optional Immune Checkpoint Inhibitors

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and immune response of Personalized neoantigen-pulsed autologous dendritic cell injections ZSNeo-DC in patients with malignant solid tumors. This single-center, open-label, real-world clinical study will enroll about 100 patients across multiple tumor-specific groups, each analyzed separately. The study follows ethical guidelines and has been approved by the appropriate institutional review board and ethics committee. Participants will receive seven subcutaneous injections of personalized dendritic cells at a fixed dose on Days 1, 8, 15, 22, 36, 50, and 64. These injections may be given alone or alongside immune checkpoint inhibitors according to standard clinical practice and the investigators decision. The dendritic cells are manufactured under Good Manufacturing Practice GMP to induce tumor-targeted immune responses. During the study, participants will be closely monitored for tumor response, progression-free survival, overall survival, safety, and specific immune reactions to the treatment. Assessments include clinical evaluations, collection of tumor tissue and blood samples for sequencing and neoantigen identification, and tracking of adverse events up to 30 days after the last treatment. The study duration extends up to 24 months for some outcomes, ensuring thorough follow-up and data collection.

Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors