Clinical trials

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.

This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM). Eligible patients with histologically confirmed, IDH1/IDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone. The primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.