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Claudin18.2 CAR-T (CT041) in Patients With Gastric or Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04404595
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : April 6, 2021
Information provided by (Responsible Party):
Carsgen Therapeutics, Ltd.

Brief Summary:
A Phase 1b, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic adenocarcinoma

Condition or disease Intervention/treatment Phase
Gastric Cancer Pancreatic Cancer Biological: CT041 Phase 1

Detailed Description:

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

Part A of the study will be Dose Escalation followed by Part B, an expansion cohort. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3+3 dose escalation and expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Phase 1b Clinical Trial 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
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2035

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy
Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. During expansion patients will be treated with the recommended dose determined in the expansion part.
Biological: CT041
treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion

Primary Outcome Measures :
  1. Incidence of Treatment Related adverse events (AEs) [ Time Frame: day 1 - month 12 ]
    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

  2. Identification of Maximum Tolerated Dose (MTD) [ Time Frame: day 1 - month 12 ]
    Incidence of dose-limiting toxicities (DLTs)

Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: day 1 - month 12 ]
    Duration of time from CT041 treatment to progression of disease

  2. Duration of Response [ Time Frame: day 1 - month 12 ]
    Duration of time from first response to progression of disease

  3. Disease Control Rate [ Time Frame: day 1 - month 12 ]
    Percentage of patients response at least 90 days

  4. Progression free survival [ Time Frame: day 1 - month 12 ]
    duration time after CT041 treatment that patient lives without worsening of disease

  5. Overall survival [ Time Frame: day 1 - month 12 ]
    duration time after CT041 treatment that patient lives

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

  1. Voluntarily signed the ICF;
  2. Age ≥ 18 and ≤ 80 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. Age ≥ 18 and ≤ 80 years with pathologically/histologically confirmed diagnosis of STAD, or PAAD who have failed or been intolerant of prior lines of systemic therapy;
  5. Estimated life expectancy > 12 weeks;
  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 6 months after T-cell infusion;

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. Patients with heavy tumor burden such as significant lung disease
  9. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding;
  10. Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation;
  11. Patients requiring anticoagulant therapy such as warfarin or heparin;
  12. Patients requiring long-term antiplatelet therapy;
  13. Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning;
  14. Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately 3 weeks before preconditioning;
  15. Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning;
  16. Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
  17. Patients have clinical significant pulmonary conditions;
  18. Patients known to have active autoimmune diseases;
  19. Patients with second malignancies in addition to STAD or PAAD;
  20. Patients have significant neurologic disorders;
  21. Patients are unable or unwilling to comply with the requirements of clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04404595

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Contact: Hong Ma, MD 3462939392

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United States, California
UCSD Recruiting
San Diego, California, United States, 92093
Contact: R Diep   
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: R Harden   
United States, Minnesota
Mayo Cancer Hospital Recruiting
Rochester, Minnesota, United States, 55905
Contact: B Johnson       johnson.brooke2@mayo.due   
United States, Texas
TX Oncology-Baylor Charles Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: A. Rodriguez   
Sponsors and Collaborators
Carsgen Therapeutics, Ltd.
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Principal Investigator: Harry H Yoon, MD Mayo
Principal Investigator: Dae Won Kim, MD Moffitt
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Responsible Party: Carsgen Therapeutics, Ltd. Identifier: NCT04404595    
Other Study ID Numbers: CT041-ST-02
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carsgen Therapeutics, Ltd.:
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases