Clinical Trial on the Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer

Jia Wei

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Gastric Cancer

Treatments: Drug: XH001 Injection; Drug: Neoantigen vaccine-induced tumor-specific T-cell injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07298200

XKY-C-008

Details and patient eligibility

About

The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastric cancer in adults. It will also learn if the combined treatment works to treat advanced gastric cancer.

The main questions it aims to answer are:

What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 months.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Tumor vaccine and tumor vaccine induced specific T-cell arm

Experimental group

Description:

After the vaccine preparation was completed, the subjects began receiving 7 cycles of XH001 injection, 400 μg, once a week. Seven days after the completion of the fifth immunization of XH001 injection, monocytes were collected from the subjects for the preparation of tumor specific T cell injection induced by the neoantigen vaccine. The T cell injection was completed within 2 to 4 weeks, reinfusion was performed after completion. Four weeks after the reinfusion of the T-cell injection, the investigators may start enhanced treatment with XH001 injection, 400 μg, once every 3-6 weeks, based on the comprehensive judgment of the subjects' safety, tolerance, preliminary efficacy, immune response, etc., until disease progression, significant deterioration of clinical symptoms, intolerable toxicity, withdrawal of informed consent, start of new anti-tumor treatment, death or loss to follow-up, whichever occurs first.

Treatment:

Drug: Neoantigen vaccine-induced tumor-specific T-cell injection

Drug: XH001 Injection