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

NCT07752953 | Recruiting

• 1 other identifier: ZSKY2026-B01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor; Cancer; Malignant Solid Tumor

Keywords

Personalized Dendritic Cell; Neoantigen Vaccine; Cancer Vaccine; Tumor Immunotherapy; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  From informed consent until 30 days after the last administration of study treatment.

Other Outcomes (2)

• Antigen-specific T-cell Response

  Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)

• Change in Peripheral Immune Cell Subsets

  Baseline, Day 22, Day 64, and disease progression/end of study (up to 24 months)

Study Arms (1)

Personalized Dendritic Cell Injection

EXPERIMENTAL

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

Interventions

Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） BIOLOGICAL

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.

Personalized Dendritic Cell Injection

Immune Checkpoint Inhibitors DRUG

Approved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.

Personalized Dendritic Cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Male or female participants aged 18 to 75 years, inclusive.
• Histologically or cytologically confirmed malignant solid tumor.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate hematologic function, including:
• Adequate hepatic function:
• Adequate renal function:
• Adequate coagulation function:
• Adequate pancreatic function:
• Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.
• Adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection by leukapheresis.
• Left ventricular ejection fraction (LVEF) ≥50%.
• Estimated life expectancy of at least 3 months.
• Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration of study treatment.
• Male participants and women of childbearing potential must agree to use highly effective contraception during treatment and for 3 months after the final administration.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• T-cell-derived malignant tumors.
• Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
• Active autoimmune disease requiring systemic treatment.
• Active uncontrolled bacterial, viral, fungal, or opportunistic infection.
• Known human immunodeficiency virus (HIV) infection.
• Active hepatitis B or hepatitis C infection that is not adequately controlled.
• Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, severe arrhythmia, or congestive heart failure.
• Severe pulmonary, hepatic, renal, neurologic, psychiatric, or other uncontrolled systemic diseases judged by the investigator to interfere with study participation.
• Pregnant or breastfeeding women.
• Receipt of systemic immunosuppressive therapy within 14 days before leukapheresis, except physiologic corticosteroid replacement.
• 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.
• Inability to undergo leukapheresis.
• Any condition that, in the investigator's opinion, would place the participant at unacceptable risk or compromise study integrity.

Sponsors & Collaborators

• ZSky Biotech Inc: lead

Study Sites (1)

Beidaihe Hospital of Qinhuangdao

Qinhuangdao, Hebei, 066100, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Xiaomin Ma, M.M

CONTACT

+0518-82342973; xiaomin.ma@zskybio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 10, 2029
• Study Completion (Estimated): August 10, 2030
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)