GPC3/Mesothelin-CAR-γδT Cells Against Cancers

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jan 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called GPC3/Mesothelin-CAR-γδT cell therapy, which is designed to help fight certain types of advanced cancers, including pancreatic, lung, liver cancers, and mesothelioma. Researchers are focused on how safe this treatment is and how well it works for patients whose cancer shows specific proteins called GPC3 or Mesothelin. This is the first phase of testing in humans, and the goal is to see if the treatment can effectively target and attack cancer cells in these patients.

To participate in this trial, patients need to have advanced cancer that expresses either GPC3 or Mesothelin and should expect to live for at least 12 weeks. Participants will receive a special type of immune cell therapy made from their own T cells, which are a part of the immune system. However, certain individuals, such as those with severe infections or other significant health issues, may not be eligible. Before joining the study, patients will need to understand and sign an informed consent form, which explains the trial's details. This trial is currently recruiting participants of all genders, aged 18 and older, who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• 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. -