Trials / Recruiting
RecruitingNCT06196294
GPC3/Mesothelin-CAR-γδT Cells Against Cancers
GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid 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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cell therapy for solid tumors | Transfer γδT cells into patients for anti-ancer therapy. |
Timeline
- Start date
- 2024-05-10
- Primary completion
- 2030-11-30
- Completion
- 2036-12-30
- First posted
- 2024-01-09
- Last updated
- 2024-06-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06196294. Inclusion in this directory is not an endorsement.