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New cell therapy combo targets tough stomach cancers

NCT ID NCT07298200

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new treatment for advanced gastric cancer that has not responded to standard therapies. It combines a special vaccine made from the patient's own tumor markers (neoantigens) with immune cells trained to attack the cancer. The main goals are to see if the treatment is safe and whether it can shrink tumors or help patients live longer.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

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

Started

Dec 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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: 1. Provision of signed and dated informed consent form. 2. Aged between 18 and 70 years old, male or female. 3. Advanced gastric cancer that has been diagnosed by histological and/or cellular pathology, and which has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage. 4. According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, there must be at least one measurable lesion as the target lesion for efficacy evaluation. The total diameter of the overall tumor lesion (excluding bone metastases) should be ≤ 100mm, and the diameter of a single tumor lesion should be ≤ 30mm. If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, then there must be clear imaging evidence of disease progression for this lesion. 5. Expected survival duration ≥ 12 weeks. 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and/or any of its excipients. 2. Central nervous system metastases with symptoms and without prior treatment, and/or meningeal metastases. 3. Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection. 4. Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis). 5. Subjects with toxic side effects from previous treatment that have not recovered to CTCAE grade≤2, excluding hair loss. 6. Subjects who received systemic steroid treatment (daily dose exceeding 10mg of prednisone equivalent) or any other form of immunosuppressive treatment within 7 days before the first administration of XH001 injection, excluding:1) Intranasal inhalation of local steroids or local steroid injection (such as intra-articular injection); 2) Systemic corticosteroid treatment not exceeding 10mg/day of prednisone or its equivalent physiological dose. 7. Subjects who have previously received therapeutic tumor vaccines or therapeutic cell therapy products. 8. Previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation, or previously received solid organ transplantation, or currently using immunosuppressive drugs. 9. Have active or poorly controlled severe infections during screening period. 10. Virological tests show positive for human immunodeficiency virus antibodies, hepatitis B surface antigen and/or hepatitis B core antibody with hepatitis B virus DNA \> 1000 IU/ml, positive for hepatitis C virus antibodies, and positive for Treponema pallidum specific antibodies. 11. Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma. 12. Any history of autoimmune diseases. 13. Known to have active pulmonary tuberculosis (TB). 14. Patients who have received systemic chemotherapy, radiotherapy, molecular targeted therapy, biological immunotherapy, hormone therapy or unapproved clinical trial drugs/instruments within 2 weeks before screening. 15. Subjects who are still participating in other clinical trials during the screening period. 16. Pregnant or lactating women. 17. Other severe, acute, or chronic medical or psychiatric conditions, or laboratory abnormalities, that, to the investigator's discretion, may increase the risks of participating in the trial or may interfere with the interpretation of the trial results.

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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

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.