CAR-γδT cell therapy targeting GPC3 and Mesothelin for cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial evaluates the safety, tolerance, and preliminary efficacy of GPC3/Mesothelin-CAR-γδT cell immunotherapy in patients with advanced solid tumors expressing GPC3 or Mesothelin. Patients will undergo biopsy to confirm protein expression, followed by the isolation and transfection of their γδT cells with CAR targeting these proteins. The modified cells will be reintroduced into the patients, potentially alongside immune checkpoint inhibitors, to enhance their anti-cancer activity. The study aims to gather data on the clinical outcomes and safety of this innovative treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

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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. -

Where it's running

• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD, PhD
• Email: zhangzhf@gzhmu.edu.cn
• Phone: 0086-020-39195965

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combination therapy using checkpoint inhibitors for advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.