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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Personalized neoantigen-pulsed autologous dendritic cell Injections (ZSNeo-DC)will be manufactured by Good Manufacturing Practice (GMP). Mature dendritic cells are administered by subcutaneous injection to induce tumor-specific immune responses.
Approved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.
Beidaihe Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
RECRUITINGObjective Response Rate (ORR)
Objective tumor response will be evaluated according to RECIST version 1.1 or other disease-specific response criteria, as applicable.
Time frame: From first study treatment until 12 months after treatment initiation
Overall Survival
Time frame: From first treatment until death from any cause, assessed up to 24 months.
Disease Control Rate
Time frame: Up to 12 months.
Best Overall Response
Time frame: Up to 12 months.
Clinical Benefit Rate
Time frame: Up to 12 months.
Incidence of Adverse Events
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Time frame: From informed consent until 30 days after the last administration of study treatment.
Progression-Free Survival
Time frame: From first study treatment until disease progression or death, assessed up to 24 months
Number of Participants With Serious Adverse Events
The number of participants experiencing serious adverse events will be summarized. Serious adverse events will be assessed according to regulatory definitions and graded according to NCI CTCAE Version 5.0.
Time frame: From informed consent through 30 days after the last administration of personalized dendritic cell injection.
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