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Can a Custom-Made immune cell vaccine turn the tide against solid tumors?

NCT ID NCT07752953

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests a personalized approach to treating advanced solid tumors. Doctors take a patient's own immune cells, train them to recognize that patient's specific cancer mutations, and inject them back under the skin. The goal is to see if these customized cells can safely trigger a stronger immune attack on the tumor, either alone or alongside standard immunotherapy drugs. Around 100 adults with various advanced solid tumors will receive seven injections over about two months, and researchers will track tumor response, survival, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Personalized neoantigen-pulsed autologous dendritic cell injections (ZSNeo-DC), a cell therapy made from the patient's own immune cells, given alone or with immune checkpoint inhibitors.
What this could lead to
If successful, this personalized cell therapy could offer a new way to control advanced solid tumors by training the immune system to target each patient's unique cancer mutations.
What could go wrong
This is an early, real-world study without a control group, so results may not prove effectiveness. Side effects from the cell injections or combination with checkpoint inhibitors are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beidaihe Hospital of Qinhuangdao

    RECRUITING

    Qinhuangdao, Hebei, 066100, China

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