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

NCT06432075 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Neoantigen T Cells
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

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

  up to 6 months

Secondary Outcomes (2)

• Response Rate

  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

• Progression free survival (PFS)

  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 (2)

• Overall Survival (OS)

  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

• Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens

  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

Study Arms (1)

Neoantigen Reactive T Cells

EXPERIMENTAL

Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;nab-paclitaxel 100-200mg/m2/D will be i.v. for 7 days before cell infusion; Cyclophosphamide 300mg/m2/D will be i.v. for 2 and 3 days before cell infusion; NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4 doses;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 1000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment.

Biological: Neoantigen Reactive T Cells(NRTs)

Interventions

Neoantigen Reactive T Cells(NRTs) BIOLOGICAL

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.

Neoantigen Reactive T Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Expected survival ≥5 months (starting from the collection of tissue samples for sequencing);
• The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2;
• The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L; Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L;
• The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN.
• Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks.

You may not qualify if:

• 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;
• Central nervous system (CNS) metastatic and/or cancerous meningitis;
• People who may be allergic to immunotherapy;
• Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study;
• Pregnant and lactating women;
• Participating in other clinical trials;
• An uncertainty that the investigator believes has an impact on the subject's safety or compliance.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Central Study Contacts

Xian Shen

CONTACT

13968888872; 13968888872@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share