Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

This is an interventional treatment trial for Gastric Cancer focused on measuring CAR-T Read More

Inclusion Criteria:

Patients are eligible for screening for potential inclusion in the study:

1. Voluntarily signed the ICF;
2. Age ≥ 18 and < 76 years with pathologically/histologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively as STAD, or pancreatic adenocarcinoma (PAAD);
3. Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;
4. Failed or been intolerant of prior lines of systemic therapy;
5. Estimated life expectancy > 4 months;
6. At least 1 measurable lesion per RECIST 1.1;
7. ECOG performance status of 0 or 1;
8. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
9. Patients should have reasonable CBC counts, renal and hepatic functions;
10. Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception;
11. Men must be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion;
12. Sufficient nutritional status.

Exclusion Criteria:

1. Pregnant or lactating women;
2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion;
3. Any uncontrolled active infection;
4. AEs from previous treatment that have not recovered;
5. Patients who have clinically significant thyroid dysfunction;
6. Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell;
7. Patients who have received prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression;
8. Untreated CNS, leptomeningeal disease or cord compression
9. Patients with heavy tumor burden such as significant lung disease
10. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding;
11. Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation;
12. Patients requiring anticoagulant therapy such as warfarin or heparin;
13. Patients requiring long-term antiplatelet therapy;
14. Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning;
15. Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately preconditioning;
16. Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning;
17. Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
18. Patients have clinical significant pulmonary conditions;
19. Patients known to have active autoimmune diseases;
20. Patients with second malignancies in addition to STAD or PAAD;
21. Patients have significant neurologic disorders;
22. Patients are unable or unwilling to comply with the requirements of clinical trial.