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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Gastric Cancer, Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT04404595

Run by

CARsgen Therapeutics Co., Ltd.

People needed

110

Starts

2020-10-23

Expected to finish

2035-09-01

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible for screening for potential inclusion in the study (* indicates inclusion criteria at Baseline (for subjects to be eligible for preconditioning)):
• 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);or biliary tract cancers (BTCs, including intrahepatic/extrahepatic cholangiocarcinoma and gallbladder cancer but not ampullary carcinoma);
• Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;
• Estimated life expectancy > 4 months*;
• Failed or been intolerant of prior lines of systemic therapy:
• For screening:
• Leukapheresis can be performed for subjects with STAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
• Leukapheresis can be performed for subjects with PAAD who are receiving first-line treatment, or,
• Leukapheresis can be performed for subjects with BTC who are receiving first-line treatment.
• Baseline*:
• Subjects with STAD who have progressed or were intolerant of at least 2 prior lines of systemic therapy, or,
• Subjects with PAAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
• Subjects with BTC who have progressed or were intolerant of at least 1 prior line of systemic therapy. For subjects with CCA with who has FGFR2 fusions or rearrangements, or IDH1-mutant must have received FDA-approved target therapies.
• 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 adequate 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 for screening (* indicates exclusion criteria for baseline as well):
• Pregnant or lactating women*;
• HIV, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or active syphilis infection;
• Any active infection requiring systemic treatment*;

Where it is running

• City of Hope — Duarte, California, United States
• University of Southern California — Los Angeles, California, United States
• UCSD — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Mayo Cancer Hospital — Rochester, Minnesota, United States
• Northwell Cancer Institute — New Hyde Park, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Ohio State University — Columbus, Ohio, United States
• TX Oncology-Baylor Charles Sammons Cancer Center — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.