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Phase 1
Age: 18Years - 75Years
All Genders
ID06196294

Phase I Study of GPC3 and Mesothelin Targeted CAR-T Cell Therapy for Advanced Solid Cancers

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-26

30

Participants Needed

1

Research Sites

317 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new immunotherapy using third-generation GPC3Mesothelin-targeted CAR-T cells for people with advanced solid cancers that express GPC3 or Mesothelin proteins. This phase I trial evaluates the safety, tolerance, and early effectiveness of this cell therapy. The study is sponsored by the Second Affiliated Hospital of Guangzhou Medical University and aims to better understand how these engineered immune cells work against various solid tumors such as pancreas, lung, liver cancer, and mesothelioma. Eligible patients will undergo tumor biopsy to confirm GPC3 or Mesothelin expression. Their blood cells are collected to isolate T cells, which are modified in the lab to target cancer cells and then multiplied. These modified cells are infused back into the patients either systemically or locally. Some patients may also receive additional antibodies targeting PD1, PDL1, or CTLA4 to enhance the immune response. The trial focuses on close monitoring during and after cell infusion to assess outcomes. Participants will be followed through regular visits to monitor for side effects and measure the therapys impact. Researchers will evaluate the number of patients experiencing dose-limiting toxicities within six months and track tumor response, including complete or partial remission rates. They will also study the persistence of the modified T cells in the body for up to six years. Throughout the study, patients heart, lung, liver, kidney, and blood functions will be assessed to ensure safety and tolerance.

CONDITIONS

Brief Title

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

Research Team

Z

Zhenfeng Zhang, MD, PhD

B

Bingjia He, MD

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