Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer.
Luis A Rojas, Zachary Sethna, Kevin C Soares...
https://pubmed.ncbi.nlm.nih.gov/37165196Actively Recruiting
Phase 1
Age: 18Years - 70Years
All Genders
ID07298200
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
Led by Jia Wei · Updated on 2026-02-25
18
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
J
Jia Wei
Lead Sponsor
N
NeoCura
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and preliminary effectiveness of a combined treatment using the tumor neoantigen vaccine called XH001 and neoantigen vaccine-induced tumor-specific T-cell injections for adults with advanced gastric cancer. This phase 1 clinical trial focuses on understanding potential medical problems from this combination therapy and whether it can shrink tumors or extend survival. Participants receive two doses of the XH001 injection at 400 micrograms each, along with two doses of tumor-specific T-cell injections. This study is non-randomized and open-label, meaning all participants receive the combined treatment. The trial aims to monitor participants for safety, tolerance, and early signs of the treatment working against cancer. During the study, researchers will track side effects and dose-related toxicities for up to 12 months after treatment. They will also evaluate tumor response, disease control, progression-free survival, overall survival, and duration of response over periods ranging from 24 to 36 months. Participants will undergo regular evaluations including imaging to measure tumor size and health assessments to monitor treatment effects and safety throughout the study period.
CONDITIONS
Brief 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
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Age between 18 and 70 years, male or female
- Diagnosed advanced gastric cancer unresponsive or intolerant to second-line standard treatment, or unsuitable for standard treatment now
- At least one measurable tumor lesion per RECIST 1.1 criteria with total diameter 64 100mm and single lesion diameter 64 30mm; if only locally treated lesion, must show clear progression
- Expected survival duration of 12 weeks or more
- Adequate organ and bone marrow function
You will not qualify if you...
- Long-term systemic use of antiallergic drugs or severe hypersensitivity (Grade 653) to XH001 injection or its components
- Untreated symptomatic central nervous system or meningeal metastases
- Immunomodulatory drug therapy within 2 weeks before starting XH001 injection
- Skin diseases preventing intradermal injection (e.g., psoriasis)
- Unresolved toxic side effects from prior treatment above CTCAE grade 2, except hair loss
- Systemic steroid treatment over 10mg prednisone daily or other immunosuppressive treatment within 7 days before XH001 injection, except low-dose or local steroids
- Prior therapeutic tumor vaccines or cell therapy products
- Previous allogeneic stem cell or bone marrow transplant, solid organ transplant, or current immunosuppressive drug use
- Active or uncontrolled severe infections during screening
- Positive HIV, hepatitis B with high viral load, hepatitis C, or syphilis antibodies
- Other cancers within 5 years except treated cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma
- History of autoimmune diseases
- Active pulmonary tuberculosis
- Systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, hormone therapy, or unapproved trial drugs within 2 weeks before screening
- Participation in other clinical trials during screening
- Pregnant or breastfeeding women
- Severe acute or chronic medical or psychiatric conditions that increase risk or affect trial results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - From reinfusion of neoantigen vaccine-induced tumor-specific T cells to 28 days after the reinfusion
Participants receive XH001 injection combined with neoantigen vaccine-induced tumor-specific T-cell injections as part of the treatment for advanced gastric cancer.
Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
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Research Team
J
JIA Wei, MD
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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