Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Neoantigen Reactive T Cells(NRTs)

    Biological/Vaccine

    Neoantigen 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

20 Participants
are divided into 1 treatment group
Group A: Neoantigen Reactive T CellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Adverse Events

using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients

Time frame
up to 6 months

Secondary outcomes

1

Response Rate

Response Rate(RR)will be evaluated according Response Evaluation Criteria in Solid Tumors

Time frame
Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
2

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.

Time frame
Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Other outcomes

1

Overall Survival (OS)

the duration is measured from the time of treatment to the time of death

Time frame
Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
2

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

Time frame
Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Locations

This trial has no locations.

Sponsors and contacts

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