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

ID#: NCT04404595

Age: 18 - 76 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: October 23, 2020

End Date: September 01, 2035

Contact Information:
Hong Ma, MD
Summary: A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers

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.