Actively Recruiting
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
Led by Jia Wei · Updated on 2026-02-25
18
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
J
Jia Wei
Lead Sponsor
N
NeoCura
Collaborating Sponsor
AI-Summary
What this Trial Is 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?
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Aged between 18 and 70 years old, male or female.
- Diagnosed with advanced gastric cancer confirmed by histological or cellular pathology.
- Cancer has failed second-line standard treatment, is intolerant to it, or unsuitable for standard treatment currently.
- At least one measurable tumor lesion per RECIST 1.1 criteria with specific size limits (total tumor diameter ≤ 100mm, single lesion diameter ≤ 30mm).
- If only one lesion has received local treatments like radiotherapy, there must be imaging evidence of disease progression.
- Expected survival duration of at least 12 weeks.
- Adequate organ and bone marrow function.
You will not qualify if you...
- Need for long-term systemic antiallergic drugs or severe hypersensitivity (grade ≥3) to XH001 or its components.
- Untreated symptomatic central nervous system metastases or meningeal metastases.
- Immunomodulatory drug therapy within 2 weeks before first XH001 administration.
- Skin diseases preventing intradermal injection (e.g., psoriasis).
- Unresolved toxic side effects from previous treatments above CTCAE grade 2, except hair loss.
- Systemic steroid treatment exceeding 10mg prednisone equivalent or other immunosuppressive treatment within 7 days before first XH001 dose, with certain exceptions.
- Prior therapeutic tumor vaccines or cell therapy products.
- Prior allogeneic hematopoietic stem cell or bone marrow transplantation, solid organ transplantation, or current immunosuppressive drugs.
- Active or uncontrolled severe infections during screening.
- Positive tests for HIV, hepatitis B or C, or Treponema pallidum with specific viral load criteria.
- Other malignancies within 5 years except treated cervical, breast, or skin basal cell carcinoma.
- History of autoimmune diseases.
- Active pulmonary tuberculosis.
- Systemic chemotherapy, radiotherapy, targeted therapy, biological immunotherapy, hormone therapy, or unapproved trial drugs/instruments within 2 weeks before screening.
- Participation in other clinical trials during screening.
- Pregnant or lactating women.
- Other severe medical or psychiatric conditions or lab abnormalities that may increase risk or interfere with results.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
J
JIA Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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