advanced gastric cancer
Conditions
Interventions
experimental group:autologous CAR T cell therapy
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years (including boundary value), both male and female; 2.Patients with locally advanced gastric cancer and metastatic gastric cancer who have failed second-line or above treatments in the past have no other feasible effective treatments, and the expected survival period of the subjects is >=12 weeks; (1)Treatment failure is defined as: the occurrence of intolerable toxicity or disease progression during treatment or tumor recurrence or metastasis after the end of treatment; (2)One or more chemotherapeutics with each line of treatment for >=1 cycle or longer; early adjuvant/neo-adjuvant therapy is allowed, if tumor recurrence develops during or =1.5x10^9/L; platelet count PLT >= 60x10^9/L; hemoglobin content Hb>=8.0g/dL; lymphocyte LYM>=0.4x10^9/L; (2)Blood biochemistry: serum creatinine 1.5xULN, creatinine clearance rate must be >50mL/min (calculated according to Cockcroft-Gault formula); serum total bilirubin 45% in cardiac color Doppler ultrasound examination within one month; 8.Fertility status: female patients of childbearing age or male patients whose sexual partners are females of childbearing age are willing to take effective contraceptive measures from the signing of the informed consent form to 6 months after the last cell infusion; females of childbearing age include premenopausal women and Women within 2 years after menopause. Subjects must agree to follow contraceptive instructions during treatment; 9.The subject must sign and date a written informed consent form; 10.The subject must be willing and able to comply with the predetermined treatment plan, laboratory examination, follow-up and other research requirements.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions cannot be selected for this study; 1.Influencing women during pregnancy and lactation; 2.Known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive); acute or chronic active hepatitis C (HCV antibody positive); Syphilis antibody positive; Epstein-Barr virus antibody positive; Cytomegalovirus (CMV) infection (IgM positive); 3.Severe infections in active phase or poor clinical control or severe infections within 4 weeks after the first blood collection; 4.At present, there is a heart disease requiring treatment or a poorly controlled hypertension (defined as systolic blood pressure >=140 mmHg and/or diastolic blood pressure > 90 mmHg after treatment with standardized antihypertensive drugs); 5.The presence of any of the following cardiac clinical symptoms or diseases: (1)Unstable angina pectoris; (2)Myocardial infarction occurred within 1 year; (3)The resting state ECG examination QTc > 450ms (male) or QTc > 470ms (female); (4)The resting state ECG examination found abnormalities of important clinical significance (such as abnormal heart rate, conduction, morphological characteristics, etc.) or complete left bundle branch block or third-degree heart block or second-degree heart block or PR Interval > 250ms; (5)There are factors that increase the risk of QTc prolongation and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or sudden death of unexplained reasons in immediate family members under 40, or prolonged periods Period concomitant medication. 6.Subjects have experienced gastrointestinal perforation, abdominal abscess, or recent (within 3 months) intestinal obstruction or imaging, clinical symptoms accompanied by intestinal obstruction; 7.Abnormal coagulation function (INR>1.5xULN), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy (such as warfarin or heparin), patients need long-term antiplatelet therapy (aspirin dose > 300mg/day; clopidogrel) Gray dose> 75mg/day); 8.Subjects who need to use corticosteroids or other immunosuppressive drugs for systemic treatment during the treatment period; 9.The blood oxygen saturation before treatment 15 mg/day of prednisone within 2 weeks before apheresis, except for inhaled steroids; 11.Before the pretreatment of lymphocyte depletion, the subject has a new arrhythmia, including but not limited to arrhythmia that cannot be controlled with drugs, hypotension that requires pressurizing agents, bacteria, fungi, or viruses that require intravenous antibiotics infection. Subjects who use test antibiotics to prevent infection are up to the investigator to determine whether they can continue to participate in the test; 12.Subjects who are currently suffering from or have a history of central nervous system diseases, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune diseases involving the central nervous system; central nervous system metastases with clinical symptoms Or meningeal metastasis, or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judged it is not suitable for inclusion; 13.Subjects who have had other malignant tumors before or a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity;objective remission rate;progression free survival;overall survival;maximum tolerated dose;duration of remission;disease control rate;pharmacokinetic evaluation index;exploratory biomarker evaluation index;tumor assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| the copy number and duration of cell survival in vivo; | — |
Countries
China
Contacts
Public ContactLu Zhengmao
Shanghai Changhai Hospital
Outcome results
None listed