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

RecruitingPhase 1Ages 18 Years - 75 YearsAllSecond Affiliated Hospital of Guangzhou Medical U…
NCT05779917 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV, HCV, HIV, et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. Other conditions that the investigators consider not appropriate. -
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What it tests

  • CAR-T cells
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Where

1 site
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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