New cell therapy combo targets tough stomach cancers
NCT ID NCT07298200
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced gastric cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGNanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal which stomach cancers will respond to immunotherapy?
- Can a direct hit to tumors make immunotherapy work better?
- Can a Two-Pronged immune attack outsmart stomach cancer?
- Acupuncture with a jolt: could needles shield nerves from chemo?
- Real-World check: does adding nivolumab to chemo help stomach cancer patients?
- Fasting during immunotherapy: a new way to boost treatment?