Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

About the study

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

1. Patients with advanced cancer that expresses Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

EXCLUSION CRITERIA

Exclusion Criteria:

Had accepted gene therapy before;
Severe virus infection such as HBV, HCV, HIV, et al;
Known HIV positivity;
Active infectious disease related to bacteria, virus,fungi,et al;
Other severe diseases that the investigators consider not appropriate;
Pregnant or lactating women;
Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
Other conditions that the investigators consider not appropriate. -

Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Pancreas Cancer,CAR-T Cell Therapy,Mesothelin,Solid Tumor, Adult

Age (in years)

18 - 75

Phase

Phase 1

Participants needed

Est. Completion Date

Mar 10, 2033

Treatment type

Interventional

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

ClinicalTrials.gov identifier

NCT05779917

Study number

FC-004

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