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

Официальное название

Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Neoantigen Reactive T Cells(NRTs)
  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.

Первичные конечные точки

• Number of participants with Adverse Events [Срок оценки: up to 6 months]

Вторичные конечные точки (2)

• Response Rate [Срок оценки: 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) [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06432075 · Neoantigen T Cells

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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