for people ages 18-76 (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Julia Carnevale
Headshot of Julia Carnevale
Julia Carnevale



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

Official Title

Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers


This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric, pancreatic or other specified digestive system cancers.

Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (CT041). Following manufacture of the drug product, subjects will receive preconditioning prior to CT041 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.


Gastric Cancer, Pancreatic Cancer, CAR-T, Pancreatic Neoplasms, anti-claudin18.2 chimeric antigen receptor T-cell therapy


You can join if…

Open to people ages 18-76

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.

You CAN'T join if...

  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.


  • UCSF
    San Francisco California 94143 United States
  • City of Hope
    Duarte California 91010 United States

Lead Scientist at UCSF

  • Julia Carnevale
    Dr. Carnevale is a physician-scientist who treats patients with gastrointestinal cancers, and also performs research into finding novel therapies for these diseases.


in progress, not accepting new patients
Start Date
Completion Date
CARsgen Therapeutics Co., Ltd.
Phase 1/2 research study
Study Type
Expecting 110 study participants
Last Updated