Advanced Solid TumorZSNeo-DC-RWSNCT07752953
Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors
A study testing Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） and Immune Checkpoint Inhibitors in people with Advanced Solid Tumor and Cancer, run by ZSky Biotech Inc at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Cancer, Malignant Solid Tumor
- What is being tested?
- Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） and Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 10 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Ability to understand and voluntarily sign written informed consent.
- Willingness and ability to comply with study procedures and scheduled follow-up assessments.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beidaihe Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066100
Yanli Gao, +86 18533588715
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumor, Cancer, Malignant Solid Tumor
- Being tested
- Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）, Immune Checkpoint Inhibitors
- Keywords
- Personalized Dendritic Cell, Neoantigen Vaccine, Cancer Vaccine, Tumor Immunotherapy, Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Immune Checkpoint InhibitorsDrug
Approved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）; Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective tumor response will be evaluated according to RECIST version 1.1 or other disease-specific response criteria, as applicable.
Measured: From first study treatment until 12 months after treatment initiation
Secondary outcomes (7)
Overall Survival
Measured: From first treatment until death from any cause, assessed up to 24 months.
Disease Control Rate
Measured: Up to 12 months.
Best Overall Response
Measured: Up to 12 months.
Clinical Benefit Rate
Measured: 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.
Measured: From informed consent until 30 days after the last administration of study treatment.
Progression-Free Survival
Measured: 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.
Measured: From informed consent through 30 days after the last administration of personalized dendritic cell injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 May 2026
- Primary completion10 Aug 2029 (estimated)
- Study completion10 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZSky Biotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752953
- Sponsor's protocol ID
- ZSKY2026-B01
- Acronym
- ZSNeo-DC-RWS
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections （ZSNeo-DC ）for Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07752953
- Acronym / sponsor ID
- ZSNeo-DC-RWS / ZSKY2026-B01
- Conditions
- Advanced Solid Tumor, Cancer, Malignant Solid Tumor
- Keywords
- Personalized Dendritic Cell, Neoantigen Vaccine, Cancer Vaccine, Tumor Immunotherapy, Solid Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ZSky Biotech IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 10 Aug 2029 (estimated)
- Study completion
- 10 Aug 2030 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Dendritic Cell Injection | Experimental | Biological: Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）, Drug: Immune Checkpoint InhibitorsParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (14 listed)
- Participants meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Personalized Dendritic Cell Injection |
| Immune Checkpoint InhibitorsApproved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice. | Drug | Personalized Dendritic Cell Injection |
Primary outcome
Objective Response Rate (ORR)
Time frame: From first study treatment until 12 months after treatment initiation
Objective tumor response will be evaluated according to RECIST version 1.1 or other disease-specific response criteria, as applicable.
7 secondary outcomes
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
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
Time frame: From informed consent through 30 days after the last administration of personalized dendritic cell injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC） and Immune Checkpoint Inhibitors in people with Advanced Solid Tumor and Cancer, run by ZSky Biotech Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Ma, M.M (+0518-82342973, xiaomin.ma@zskybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From first study treatment until 12 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.