NCT06196294RecruitingPhase 1

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial

Source: ClinicalTrials.gov · Last updated 26 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 22 Dec 2023
Start date: 10 May 2024
Primary completion date: 30 Nov 2030
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Diseases: Mesothelioma, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer
NCT number: NCT06196294

What you commit to

Study type: Interventional · Phase 1
Planned participants: 30
From 10 May 2024 to the primary completion date, 30 Nov 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Had accepted gene therapy before;
Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);

Other illness

Severe virus infection such as HBV, HCV, HIV, et al;
Known HIV positivity;
Active infectious disease related to bacteria, virus,fungi,et al;
Other severe diseases that the investigators consider not appropriate;
Other conditions that the investigators consider not appropriate. -

Other

Pregnant or lactating women;

Who the study is looking for

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.
\-

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status	Guangzhou	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.