solid tumor
Conditions
Interventions
Group one:RD07 cell injection
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, gender is not limited; 2. Claudin18.2 positive confirmed by histology or cytology (the proportion of positive cells > 30% and the staining intensity >= 2+; the specimen is acceptable within 1 year, and re-biopsy is required for more than 1 year) advanced digestive tract malignant tumor, etc. ; 3. Those who are ineffective in second-line treatment, or who are unwilling to perform or cannot tolerate second-line treatment after failure of first-line 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 (2 slices, slice thickness 5-8 mm); or the short diameter of lymph node lesions must be >= 15 mm; 5. ECOG score 0-2 points; 6. Blood routine neutrophil count >= 1.5x10^9/L, platelets >= 75x10^9/L, hemoglobin >= 80g/L; 7. Serum total bilirubin = 60mL/min; 8. Echocardiography shows left ventricular ejection fraction (LVEF) >= 50%; 9. The estimated survival period is more than 3 months; 10. The subjects or their legal guardians voluntarily participate in this trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of allergy to any component in the cell product; 2. Those who have received Claudin18.2-targeted monoclonal antibody or cell therapy in the past; 3. Uncontrolled intracranial metastases (except those with stable disease for >=8 weeks and no need for glucocorticoid therapy within 4 weeks after the first dose); 4. A history of acute pancreatitis or severe active upper gastrointestinal disease within 4 weeks, such as upper gastrointestinal bleeding; 5. Received anti-tumor therapy before apheresis, and it should be excluded if it meets any of the following: received chemotherapy and small molecule targeted therapy within 2 weeks; received radiotherapy within 4 weeks; received monoclonal antibody therapy and the last monoclonal antibody transfusion Note that the period from apheresis is less than 2 half-lives; 6. Those who have used granule/granule-monoline colony stimulating factor within 2 weeks before screening 7. Uncontrolled active infection (except simple urinary tract infection and bacterial pharyngitis); 8. HBV DNA copy number > upper limit of normal; HCV, HIV, syphilis antibody positive or DNA detection exceeding the upper limit of normal; 9. Autoimmune disease subjects in need of treatment or subjects in need of immunosuppressive treatment; 10. The subject has a history of other primary cancers, except for the following cases: non-melanoma cured by resection, such as basal cell carcinoma of the skin; cervical carcinoma in situ, local prostate cancer, and cervical carcinoma in situ with a disease-free survival period of >=2 years after adequate treatment. Ductal carcinoma in situ; 11. The subject has a history of alcoholism, drug addiction or mental illness; 12. Those who have participated in other clinical trials within 2 weeks before screening; 13. Pregnant, lactating women and subjects who are fertile and cannot take effective contraceptive measures (whether male or female); 14. Any other situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLT); | — |
Countries
China
Contacts
Public ContactZhou Yuhong
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed