| Eligibility |
Inclusion Criteria:
- 1) Age =18 years old and <75 years old, gender is not limited; 2) Claudin18.2 positive
confirmed by histology or cytology (the proportion of positive cells is =10% and the
staining intensity is =1+; the specimen is acceptable within 1 year, and re-biopsy is
required for more than 1 year) advanced gastric cancer, gastroesophageal combination
solid tumors such as adenocarcinoma and pancreatic cancer; 3) Patients with gastric
cancer and gastroesophageal junction adenocarcinoma who are ineffective in second-line
standard therapy, or who are unwilling to perform or cannot tolerate second-line
standard therapy; pancreatic cancer patients who fail or cannot tolerate first-line
therapy; for other tumor types patients, they should meet the requirements of the
existing standard of care for ineffective or intolerable standard treatment; 4)
Referring to the RECIST 1.1 standard, there is at least one measurable lesion:
according to CT or MRI evaluation, the longest diameter of the lesion is at least 10
mm (slice thickness 5 mm); or the short diameter of the lymph node lesion must be =15
mm; 5) ECOG score 0-2 points; 6) Blood routine neutrophil count =1.5×109/L; hemoglobin
=80g/L and platelets =75×109/L (no blood transfusion within 14 days); 7) Creatinine
clearance rate > 60ml/min (Cockcroft and Gault formula); for patients without liver
involvement, serum total bilirubin is less than or equal to 1.5 times the upper limit
of the normal value, and both serum ALT and AST are less than or equal to 3 times the
upper limit of the normal value range; For liver violations, serum total bilirubin is
=3 times the upper limit of the normal value, and both serum ALT and AST are =5 times
the upper limit of the normal value range; 8) Echocardiography shows left ventricular
ejection fraction (LVEF) = 50%; 9) The estimated survival period is more than 3
months; The subjects or their legal guardians voluntarily participated in this trial
and signed the informed consent.
Exclusion Criteria:
- 1) Those who have received Claudin18.2-targeted monoclonal antibody or cell therapy in
the past; 2) Uncontrolled intracranial metastases (except those with stable disease
for =8 weeks and no need for glucocorticoid therapy within 4 weeks after the first
dose); 3) Acute pancreatitis or severe active upper gastrointestinal disease history
within 4 weeks, such as upper gastrointestinal bleeding, etc.; 4) Receive anti-tumor
therapy before infusion, if any of the following are met, it should be excluded:
Received chemotherapy and small molecule targeted therapy within 2 weeks; Received
radiotherapy within 4 weeks; Have received monoclonal antibody treatment and the last
monoclonal antibody infusion is less than 2 half-lives from apheresis;
- Received traditional Chinese medicine, Chinese patent medicine, etc. for the main
purpose of anti-tumor treatment within 1 week.
5) Those who used granule/granule-monoline colony-stimulating factor (G/GM-GSF)
within 2 weeks before screening; 6) Patients who must use steroid hormones during
CAR-T infusion (except for topical or inhaled steroid hormones); patients who are
receiving systemic steroid therapy before screening and who are judged by the
investigator to need long-term use of systemic steroid therapy during treatment.
subjects (except inhalation or topical use); and subjects treated with systemic
steroids within 72 hours before cell infusion (except inhalation or topical use);
7) Those with a history of serious heart disease, including but not limited to:
history of acute myocardial infarction within 12 months, unstable angina
pectoris, chronic heart failure of grade =III (standard of New York Heart
Association), and electrocardiogram showing QT History of prolonged interval or
severe arrhythmia; 8) Those with a history of craniocerebral trauma, disturbance
of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic
disease, etc.; 9) Uncontrolled severe active infection (except for simple urinary
tract infection and bacterial pharyngitis); 10) Subjects with positive hepatitis
B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral
blood HBV DNA >1000 copies/ml at screening; hepatitis C virus (HCV) antibody
positive or peripheral blood HCV RNA positive ; Human immunodeficiency virus
(HIV) antibody positive; Syphilis antibody positive; 11) Autoimmune disease
subjects in need of treatment or subjects in need of immunosuppressive treatment;
12) The subject has a history of other primary cancers, except for the following:
Non-melanoma cured by resection, such as skin basal cell carcinoma; Cervical
carcinoma in situ, local prostate cancer, and ductal carcinoma in situ with a
disease-free survival period of =2 years after adequate treatment; 13) The
subject has a history of alcoholism, drug addiction or mental illness; 14)
Inoculated with live or attenuated or inactivated vaccine within 4 weeks before
screening; 15) Those who have a history of allergy to any component in the cell
product; 16) Those who have participated in other clinical trials within 2 weeks
before screening; 17) Pregnant, lactating women and subjects who are fertile and
cannot take effective contraceptive measures (whether male or female); Any other
condition that the investigator believes may increase the risk to the subject or
interfere with the results of the trial.
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