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Trial Title:
Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer
NCT ID:
NCT06432075
Condition:
Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Neoantigen Reactive T Cells(NRTs)
Description:
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.
Arm group label:
Neoantigen Reactive T Cells
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.
Detailed description:
The tumor-specific "none-self" immunogenic neoantigens encoded by either viral genes or
somatic mutation genes, possess the potential to induce specific anti-cancer immunity,
including cellular and humoral immune responses. Today, numerous clinical trials
demonstrate that although these "none-self" antigens initiate the antigen-specific
immunoglobulin G antibodies and cluster of differentiation 4（CD4）+/cluster of
differentiation 8（CD8）+T-cells response, not all of them show a clinical benefit in the
response rate, progression-free survival or overall survival.Personalized cell therapy
maybe own a breakthrough in the treatment of those gastric cancer patients without
standard options.The investigators' center has successfully established a new method for
preparing personalized neoantigen reactive T cells(NRTS) for adoptive cell therapy(ACT).
Today, the investigators will carry out a single arm clinical prospective study of NRTs
for the treatment of Chinese patients with advanced gastric cancer. Participants are
assigned to receive 4 circles of cell therapy, and IL-2 continuous intravenous
infusion（CIV） will also be given for 5 consecutive days after each time's cell infusion.
The safety and clinical response rate（RR） are evaluated. Biomarkers and immunological
markers are also monitored.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily join the study and sign the informed consent;
2. Age: 18-75 years old, male or female;
3. 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".) ;
4. Have at least one measurable lesion according to imRECIST evaluation criteria;
5. Expected survival ≥5 months (starting from the collection of tissue samples for
sequencing);
6. The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2;
7. The following hematological indicators should be met: neutrophil count ≥ 1.5×109/L;
Hemoglobin ≥ 10.0 g/dL; Platelet count ≥ 50×109/L;
8. 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.
9. 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.
Exclusion Criteria:
1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis;
2. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease
or what the investigator considers Other diseases not included in the group;
3. Patients with a history of bone marrow or organ transplantation; Patients with
coagulation dysfunction;
4. Patients with immune deficiency diseases or autoimmune diseases who are treated with
immunosuppressive drugs;
5. Central nervous system (CNS) metastatic and/or cancerous meningitis;
6. People who may be allergic to immunotherapy;
7. Drug abuse, clinical or psychological or social factors that affect informed consent
or the conduct of the study;
8. Pregnant and lactating women;
9. Participating in other clinical trials;
10. An uncertainty that the investigator believes has an impact on the subject's safety
or compliance.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432075
