GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial

Trial ID: NCT06196294

Interventional - Phase 1 - Recruiting

The third generation of GPC3/mesothelin targeted CAR-γδT cells 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-γδT cells for immunotherapy of human cancer patients with GPC3 or Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/Mesothelin-CAR-γδT cell immunotherapy on human cancers will firstly be evaluated.

Conditions

• Pancreas Cancer
• Lung Cancer
• Liver Cancer
• Mesothelioma
• CAR-T Cell Therapy
• Solid Tumor, Adult

Interventions

• Cell therapy for solid tumors

Eligibility

Inclusion criteria

• Patients with advanced cancer that expresses GPC3 or 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 GPC3/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

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