A Study to Evaluate the Safety and Efficacy of Autologous Claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma


About this study

This study aims to evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in patients with advanced adenocarcinoma of the stomach or gastroesophageal junction (STAD) or pancreatic adenocarcinoma (PAAD) and identify the maximum tolerated dose (MTD) and a recommended Phase 2 dose (RP2D) of CT041 therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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

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

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.

Eligibility last updated 8/19/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zhaohui Jin, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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