An interventional study of Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） and Immune Checkpoint Inhibitors in Advanced Solid Tumor, Cancer and Malignant Solid Tumor, sponsored by ZSky Biotech Inc. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by ZSky Biotech Inc · Not applicable, Interventional, and Treatment
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.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Participants will receive personalized neoantigen-pulsed autologous dendritic cell Injections administered subcutaneously at a fixed dose of 1×10\^7 cells per injection on Days 1, 8, 15, 22, 36, 50, and 64. Immune checkpoint inhibitors may be administered concomitantly according to routine clinical practice and investigator judgment.
Biological: Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） · Drug: Immune Checkpoint Inhibitors
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.
Objective 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.
Antigen-specific T-cell Response
Antigen-specific T-cell activation will be evaluated using immunological assays including ELISPOT and flow cytometry.
Time frame: Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)
Change in Peripheral Immune Cell Subsets
Changes in peripheral immune cell populations, including T-cell subsets and other immune-related cell populations, following personalized dendritic cell therapy will be assessed. Results will be reported as changes from baseline in immune cell proportions or absolute counts.
Time frame: Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)
Plan to share: No — Individual participant data collected during this study will not be made publicly available.
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ZSky Biotech Inc