Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors (ZSNeo-DC-RWS)

Real-World Study of Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections （ZSNeo-DC ）for Malignant Solid Tumors

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 Overview

• Status: Recruiting
• Conditions: Cancer; Advanced Solid Tumor; Malignant Solid Tumor
• Intervention / Treatment: Biological: Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）; Drug: Immune Checkpoint Inhibitors

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaomin Ma, M.M; Phone Number: +0518-82342973; Email: xiaomin.ma@zskybio.com

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066100
      • Recruiting
      • Beidaihe Hospital of Qinhuangdao
      • Contact: Yanli Gao; Phone Number: +86 18533588715

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must meet all of the following criteria:

  1. Male or female participants aged 18 to 75 years, inclusive.
  2. Histologically or cytologically confirmed malignant solid tumor.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  4. Adequate hematologic function, including:
  5. Adequate hepatic function:
  6. Adequate renal function:
  7. Adequate coagulation function:
  8. Adequate pancreatic function:
  9. Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.
  10. Adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection by leukapheresis.
  11. Left ventricular ejection fraction (LVEF) ≥50%.
  12. Estimated life expectancy of at least 3 months.
  13. Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration of study treatment.
  14. Male participants and women of childbearing potential must agree to use highly effective contraception during treatment and for 3 months after the final administration.
  15. Ability to understand and voluntarily sign written informed consent.
  16. Willingness and ability to comply with study procedures and scheduled follow-up assessments.

Exclusion Criteria:

• Participants meeting any of the following criteria will be excluded:

  1. T-cell-derived malignant tumors.
  2. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  3. Active autoimmune disease requiring systemic treatment.
  4. Active uncontrolled bacterial, viral, fungal, or opportunistic infection.
  5. Known human immunodeficiency virus (HIV) infection.
  6. Active hepatitis B or hepatitis C infection that is not adequately controlled.
  7. Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, severe arrhythmia, or congestive heart failure.
  8. Severe pulmonary, hepatic, renal, neurologic, psychiatric, or other uncontrolled systemic diseases judged by the investigator to interfere with study participation.
  9. Pregnant or breastfeeding women.
  10. Receipt of systemic immunosuppressive therapy within 14 days before leukapheresis, except physiologic corticosteroid replacement.
  11. Receipt of blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days before PBMC collection.
  12. Inability to undergo leukapheresis.
  13. Any condition that, in the investigator's opinion, would place the participant at unacceptable risk or compromise study integrity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Personalized Dendritic Cell Injection; 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）; 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.; Drug: Immune Checkpoint Inhibitors; Approved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective tumor response will be evaluated according to RECIST version 1.1 or other disease-specific response criteria, as applicable.	From first study treatment until 12 months after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		From first treatment until death from any cause, assessed up to 24 months.
Disease Control Rate		Up to 12 months.
Best Overall Response		Up to 12 months.
Clinical Benefit Rate		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.	From informed consent until 30 days after the last administration of study treatment.
Progression-Free Survival		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.	From informed consent through 30 days after the last administration of personalized dendritic cell injection.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antigen-specific T-cell Response	Antigen-specific T-cell activation will be evaluated using immunological assays including ELISPOT and flow cytometry.	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.	Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)

Collaborators and Investigators

• Sponsor: ZSky Biotech Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): August 10, 2029
• Study Completion (Estimated): August 10, 2030

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Tumor Immunotherapy; Solid Tumor; Cancer Vaccine; Personalized Dendritic Cell; Neoantigen Vaccine
• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Immune Checkpoint Inhibitors
• Other Study ID Numbers: ZSKY2026-B01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data collected during this study will not be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No