solid tumor
Conditions
Interventions
Case series:RD07 cell injection
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 70 years old; 2) Advanced gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer diagnosed by pathology or histology as Claudin 18.2-positive (IHC: tumor positive cell ratio of > 10% and staining intensity >=2+); 3) Those who fail to receive the second-line treatment, or are unwilling to receive the second-line treatment again after the failure of the first-line treatment or cannot tolerate the second-line treatment; 4) At least one measurable lesion according to RECIST 1.1; 5) ECOG score 0-2; 6) Blood routine neutrophil count >= 1.5 x 10^9/L, platelet >= 60 x 10^9/L;(If the patient is not satisfied at the time of screening, but meets the requirements of the screening period within 2 weeks, he/she can be selected); 7) Serum total bilirubin acuities 51 mol/L, serum ALT and AST were normal or less range limit three times, creatinine clearance rate (Ccr) > 70 ml/min (Cockcroft and Gault formula); 8) Echocardiography showed left ventricular ejection fraction (LVEF) >= 50%; 9) Subjects have no active pulmonary infection; 10) The estimated survival time is more than 3 months; 11) No difficulties or contraindications of collecting peripheral blood mononuclear cells were found by the researchers; 12) Subjects or their legal guardians participate in this study voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Have a history of allergy to any one ingredient in cell products; 2) prior claudin 18.2-targeted mAb or cell therapy; 3) Patients with uncontrolled intracranial metastases (except those with stable disease >=8 weeks and no glucocorticoid therapy is expected to be required within 4 weeks after the first administration); 4) Patients who had received antitumor therapy before but still did not recover their toxicity (the toxicity did not recover to =grade III (New York Heart Association standard), etc.; 9) Previous history of severe cerebrovascular accidents (except those without obvious neurological dysfunction, such as lacunar cerebral infarction, etc.); 10) A history of prolonged QT interval or severe arrhythmia indicated by electrocardiogram; 11) Patients with hypertension or diabetes with poor control; 12) Uncontrolled active infection (except simple urinary tract infection and bacterial pharyngitis); 13) Patients with HBsAg positive and HBV DNA copy number > 1000, if HBV DNA copy number <=1000, they need routine anti-HBV therapy after inclusion; HCV, HIV, syphilis antibody positive or DNA test exceeds the upper limit of the normal value; 14) Subject has a history of other primary cancers except for: as cured by resection of melanoma skin basal cell carcinoma; fully disease-free survival after treatment of 2 years or more local prostate cancer, cervical carcinoma in situ, ductal carcinoma in situ; 15) Subjects with autoimmune diseases requiring treatment or subjects requiring immunosuppressive therapy; 16) Subjects have a history of alcohol, drug abuse or mental illness; 17) Screening participants who had participated in other clinical trials within the previous 2 weeks; 18) Pregnant and lactating women and fertile subjects who are unable to take effective contraceptive measures (both male and female); 19) With moderate or more than equal amount of peritoneal effusion, or after 2 weeks of conservative medical treatment (such as diuresis, sodium restriction, excluding drainage of peritoneal effusion), ascites still presented progressive increase; 20) Any other conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLT);Incidence of treatment-related adverse events (AES); | — |
Countries
China
Contacts
Public ContactJifeng Feng
Jiangsu Cancer Hospital
Outcome results
None listed