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GPC3/​Mesothelin-CAR-γδT Cells Against Cancers

Published: January 12, 2024

Primary Outcome Measures

Number of Patients with Dose Limiting Toxicity A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the γδT cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Secondary Outcome Measures

Percent of Patients with best response as either complete remission or partial remission. Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate. Six months
Median γδT cell persistence Median γδT cell persistence will be measured by quantitative rt-PCR. Six years

Inclusion Criteria

1. 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

  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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