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Trial Title:
GPC3/Mesothelin-CAR-γδT Cells Against Cancers
NCT ID:
NCT06196294
Condition:
Pancreas Cancer
Lung Cancer
Liver Cancer
Mesothelioma
CAR-T Cell Therapy
Solid Tumor, Adult
Conditions: Official terms:
Mesothelioma
Pancreatic Neoplasms
Conditions: Keywords:
Solid Tumor
CAR-γδT
γδT
GPC3
Mesothelin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Cell therapy for solid tumors
Description:
Transfer γδT cells into patients for anti-ancer therapy.
Arm group label:
CAR-γδT cell therapy for solid tumor
Arm group label:
γδT cell therapy for solid tumor
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 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.
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 or IHC;
3. Collect blood from the patients and isolate mononuclear cells, select and grow γδT
cells and transfect the γδT cells with GPC3 or Mesothelin targeting CAR, amplify the
transfected γδT cells as needed, test the quality and killing activity of the
CAR-γδT cells and then transfer them back the patients via systemic or local
injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4
antibodies may be applied;
5. Evaluate the clinical results as needed.
Criteria for 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. -
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510260
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenfeng Zhang, MD,PhD
Email:
zhangzhf@gzhmu.edu.cn
Contact backup:
Last name:
Deji Chen, MD,PhD
Phone:
+86-020-34153532
Email:
chendeji2003@163.com
Start date:
May 10, 2024
Completion date:
December 30, 2036
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Source:
Second Affiliated Hospital of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196294
