XH001 plus personalized neoantigen vaccine–induced T-cell therapy for advanced stomach cancer

A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer.

This trial tests whether combining XH001 with a personalized neoantigen vaccine and vaccine-induced tumor-specific T cells is safe and can shrink tumors in adults with advanced gastric (stomach) cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07298200 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives adults with advanced gastric cancer injections of XH001 together with tumor neoantigen vaccine–induced tumor-specific T cells to measure safety, tolerability, and early anti-tumor activity. Eligible participants have measurable disease by RECIST 1.1, have failed or are unsuitable for second-line standard treatments, and must have adequate organ and bone marrow function. The primary focus is on adverse events and tolerance, with secondary observations of tumor response and preliminary effects on survival. The protocol is led by Jia Wei at Nanjing Drum Tower Hospital in collaboration with NeoCura.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed advanced gastric cancer who have measurable lesions, have failed or are unsuitable for second-line therapy, expect to live at least 12 weeks, and have adequate organ and marrow function.

Not a fit: Patients with poor performance status, rapidly progressing or widespread disease, inadequate organ function, or those who can still receive effective standard treatments are unlikely to benefit from this experimental combination.

Why it matters

Potential benefit: If successful, this approach could offer a new immunotherapy option that shrinks tumors and may extend survival for some people with advanced gastric cancer.

How similar studies have performed: Early-phase studies of neoantigen vaccines and adoptive neoantigen-specific T-cell therapies have shown promising signals in several cancers, but evidence specifically in advanced gastric cancer is limited and remains experimental.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: JIA Wei, MD

Conditions Advanced Gastric Cancer; Tumor neoantigen; Tumor neoantigen induced tumor-specific T -cell