Trials / Recruiting
RecruitingNCT05779917
Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR-T cells | Transfer CAR-T cells into patients for anti-ancer therapy. |
Timeline
- Start date
- 2023-03-10
- Primary completion
- 2029-03-10
- Completion
- 2036-03-10
- First posted
- 2023-03-22
- Last updated
- 2024-06-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05779917. Inclusion in this directory is not an endorsement.