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Trial Title:
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers
NCT ID:
NCT05779917
Condition:
Pancreas Cancer
CAR-T Cell Therapy
Mesothelin
Solid Tumor, Adult
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreas Cancer
CAR-T
Mesothelin
Solid Tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Use engineered CAR-T cells to kill cancer cells with mesothelin overexpression.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR-T cells
Description:
Transfer CAR-T cells into patients for anti-ancer therapy.
Summary:
The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of
IL21 and scfv against PD1 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-T cells for immunotherapy of human cancer patients
with Mesothelin expressions. In this phase I study, the safety, tolerance, and
preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will
firstly be evaluated.
Detailed description:
1. Choose appropriate patients with advanced pancreatic cancer or other cancers, with
written consent for this study;
2. Perform biopsy to determine the expression of Mesothelin of the tumors by western
blotting or IHC;
3. Collect blood from the patients and isolate mononuclear cells, activate the T cells
and transfect the T cells with Mesothelin targeting CAR, amplify the transfected T
cells as needed, test the quality and killing activity of the CAR-T 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 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
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
Phone:
+862039195966
Email:
zhangzhf@gzhmu.edu.cn
Start date:
March 10, 2023
Completion date:
March 10, 2036
Lead sponsor:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Fapon Biotherapy Inc.
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/NCT05779917
