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?
Provision of signed and dated informed consent form.
Aged between 18 and 70 years old, male or female.
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.
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.
Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (≥Grade 3) to XH001 injection and/or any of its excipients.
Central nervous system metastases with symptoms and without prior treatment, and/or meningeal metastases.
Having received immunomodulatory drug therapy within 2 weeks prior to the first administration day (D1) of XH001 injection.
Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis).
Sequential
XH001 Injection
DrugmRNA tumor neoantigen vaccine
Tumor vaccine-induced specific T-cell injection
DrugAdoptive Cell Transfer Therapy product
Adverse Event
Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (Based on Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0).
Dose Limiting Toxicity
Safety events occurring within 28 days after the reinfusion of neoantigen vaccine-induced tumor-specific T cells and related to neoantigen vaccine-induced tumor-specific T cells.
ORR
Objective Response Rate
PFS
Progression-Free Survival
DCR
Disease Control Rate
OS
Overall Survival
Click on the lead sponsor to view all of their trials.
Jia Wei
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor institution
NeoCura
Collaborator
