Clinical Trial

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

Study acronym: ZSNeo-DC-RWS
Recruiting
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Summary
This is a prospective, single-center, open-label, real-world clinical study designed to evaluate the safety, efficacy, and immunogenicity of Personalized neoantigen-pulsed autologous dendritic cell Injections (ZSNeo-DC)in patients with malignant solid tumors. The study protocol received approval from the institutional review board and ethics committee of Beidaihe Hospital, adhering to ethical guidelines. Written informed consent was obtained from all participants in accordance with the principles of the Declaration of Helsinki. Approximately 100 patients will be enrolled in multiple tumor-specific cohorts which will be independently statistically analyzed. ZSNeo-DC will be manufactured by Good Manufacturing Practice (GMP). Participants will receive seven subcutaneous injections of personalized DCs administered on Days 1, 8, 15, 22, 36, 50, and 64, either as monotherapy or in combination with immune checkpoint inhibitors according to routine clinical practice. Tumor response, progression-free survival, overall survival, safety, and antigen-specific immune responses will be evaluated throughout the study.
Trial Details
NCT Number NCT07752953
Lead Sponsor ZSky Biotech Inc
Conditions Advanced Solid Tumor, Cancer, Malignant Solid Tumor
Enrollment 100 participants
Start Date 2026-05-01
Primary Completion 2029-08-10 (estimated)
Study Completion 2030-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-07