Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial

Trial ID: NCT05779917

Interventional - Phase 1 - Recruiting

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.

Conditions

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

Interventions

• CAR-T cells

Eligibility

Inclusion criteria

• 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

• 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. -

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Source: Clinicaltrials.gov

Search more clinical trials on myTomorrows