RecruitingRecruiting
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers
NCT05779917 · Second Affiliated Hospital of Guangzhou Medical University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
About this study
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.
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.
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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. -
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-10
Estimated completion: 2036-03-10
Last updated: 2024-06-25
Interventions
Biological: CAR-T cells
Primary outcomes
- • Number of Patients with Dose Limiting Toxicity (six months)
Sponsor
Second Affiliated Hospital of Guangzhou Medical University · other
With: Fapon Biotherapy Inc.
Contacts & investigators
ContactZhenfeng Zhang, MD, PhD · contact · zhangzhf@gzhmu.edu.cn · 0086-020-39195965
ContactBingjia He, MD · contact · 464677938@qq.com · +862039195965
InvestigatorZhenfeng Zhang, MD, PhD · principal_investigator, Second Affiliated Hospital of Guangzhou Medical University
All locations (1)
The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China