About this trial
The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily join the study and sign the informed consent;
Age: 18-75 years old, male or female;
Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the "Gastric Cancer Diagnosis and Treatment Guide" issued by China's "Chinese Clinical Oncology Society".) ;
Have at least one measurable lesion according to imRECIST evaluation criteria;
Disqualifiers
Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis;
Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group;
Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction;
Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs;
Trial design
Single group
Treatments tested in this trial
Neoantigen Reactive T Cells(NRTs)
Biological/VaccineNeoantigen Reactive T Cells in an expected volume of 100 milliliter(mL) will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with Adverse Events
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Secondary outcomes
Response Rate
Response Rate(RR)will be evaluated according Response Evaluation Criteria in Solid Tumors
Progression free survival (PFS)
the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented.
Other outcomes
Overall Survival (OS)
the duration is measured from the time of treatment to the time of death
Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens
T cells in the peripheral blood stimulated by tumor antigens for 24 hr,and then Interferon-gama secretion is measured
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: