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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2035
  • participants needed
    110
  • sponsor
    CARsgen Therapeutics Co., Ltd.
Updated on 4 October 2022
measurable disease
pancreatic adenocarcinoma
adenocarcinoma
pancreatic cancers

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

Description

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.

Details
Condition Gastric Cancer, Pancreatic Cancer
Treatment CT041
Clinical Study IdentifierNCT04404595
SponsorCARsgen Therapeutics Co., Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are eligible for screening for potential inclusion in the study
Voluntarily signed the ICF
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)
Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay
Failed or been intolerant of prior lines of systemic therapy
Estimated life expectancy > 4 months
At least 1 measurable lesion per RECIST 1.1
ECOG performance status of 0 or 1
Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis
Patients should have reasonable CBC counts, renal and hepatic functions
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
Men must be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion
Sufficient nutritional status

Exclusion Criteria

Pregnant or lactating women
HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion
Any uncontrolled active infection
AEs from previous treatment that have not recovered
Patients who have clinically significant thyroid dysfunction
Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell
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
Patients with heavy tumor burden such as significant lung disease
Untreated CNS, leptomeningeal disease or cord compression
Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding
Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation
Patients requiring anticoagulant therapy such as warfarin or heparin
Patients requiring long-term antiplatelet therapy
Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning
Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning
Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients
Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately preconditioning
Patients have clinical significant pulmonary conditions
Patients known to have active autoimmune diseases
Patients with second malignancies in addition to STAD or PAAD
Patients have significant neurologic disorders
Patients are unable or unwilling to comply with the requirements of clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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