Status:
RECRUITING
GPC3/Mesothelin-CAR-γδT Cells Against Cancers
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Pancreas Cancer
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
1. Choose appropriate patients with advanced solid cancers, with written consent for this study; 2. Perform biopsy to determine the expression of GPC3 or Mesothelin of the tumors by western blotting o...
Eligibility Criteria
Inclusion
- 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
- Had accepted gene therapy before;
- Severe virus infection such as HBV, HCV, HIV, et al;
- Known HIV positivity;
- Active infectious disease related to bacteria, virus,fungi,et al;
- Other severe diseases that the investigators consider not appropriate;
- Pregnant or lactating women;
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
- Other conditions that the investigators consider not appropriate. -
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2036
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06196294
Start Date
May 10 2024
End Date
December 30 2036
Last Update
June 26 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260