TCRx_T Cells for Advanced or Recurrent Gastric/Gastroesophageal Junction Cancer After Failure of First Chemotherapy

Korábbi kezelés

• Patients with previous non-gastric/gastroesophageal junction malignant tumor
• Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures
• Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration
• Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish
• Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia
• Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study

Más betegség

• History of severe acute allergy
• There is an uncontrolled infection
• History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
• History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure
• Poor control of hypertension
• Evidence of active bleeding or bleeding tendency
• Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation

Laborértékek

• QT interval >480ms

Egyéb

• History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
• Grade 3 or 4 diarrhea
• Pregnant or lactating women
• Men or women planning to become pregnant within the next six months

• Age 18-70 years old;
• Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
• Expected survival time ≥ 3 months
• Eastern Cooperative Oncology Group (ECOG) score 0-2
• According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
• Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕)
• Normal liver and kidney function: serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) <2.5UNL, alkaline phosphatase <5UNL; serum creatinine <1.5mg/dl;
• Men and women must take appropriate contraceptive measures.