NCT06432075Not yet recruitingEarly phase 1
Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer
Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 29 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06432075
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 1 Jun 2024 to the primary completion date, 1 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs;
- Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study;
Other illness
- 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;
- People who may be allergic to immunotherapy;
Other
- Central nervous system (CNS) metastatic and/or cancerous meningitis;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.