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Immunomodulating Agents

Transfer γδT cells into patients for anti-ancer therapy.

Cell therapy for solid tumors

Zhenfeng Zhang, MD, PhD

Bingjia He, MD

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.

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.

GPC3/Mesothelin-CAR-γδT Cells Against Cancers

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

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the γδT cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Median γδT cell persistence will be measured by quantitative rt-PCR.

Second Affiliated Hospital of Guangzhou Medical University

Dosage: the total dosage of reinfusion is 0.2-5 × 10\^6 / kg, which is determined according to the body weight of the subject and the effective content of cell preparation.

Chimeric antigen receptor modified γδ T cells

Xingbing Wang

Huimin Meng

xingbing wang, doctor

This is a study on the clinical application of chimeric antigen receptor modified γδ T cells (CAR - γδ T cells) in relapsed and refractory CD7 Positive T cell-derived malignant tumors.The main purpose of this study was to evaluate the efficacy of car - γ δ T cell infusion in patients with relapsed and refractory CD7 Positive T cell-derived malignancies.

γδT cells are known as "a great candidate for car-t cells". Although they only account for 2% - 5% of all T cells in our body, they are a natural killer.

CD7 is recognized as a sensitive marker of T-ALL, and its expression level on T-ALL cells is opposite to CD3: compared with normal T cells, the expression level of CD7 on T-ALL cells is significantly increased (P \< 0.001), while the expression level of CD3 on T-ALL cells is significantly decreased (P \< 0.001). At the same time, CD7 expression is absent in about 10% of normal T cells, and these CD7 negative T cells have the ability of normal T cells to express cytokines. Therefore, CD7 has become a potential target for the treatment of T-ALL because of its specificity and safety.

CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors

Clinical Application of Chimeric Antigen Receptor Modified γδ T Cells（CAR - γ δ T Cells） in Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors

Anhui Provincial Hospital

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GPC3/Mesothelin-CAR-γδT Cells Against Cancers	NCT06196294	Pancreas Cancer Lung Cancer Liver Cancer Mesothelioma CAR-T Cell Ther... Solid Tumor, Ad...	Cell therapy fo...	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
CAR - γ δ T Cells in the Treatment of Relapsed and Refractory CD7 Positive T Cell-derived Malignant Tumors	NCT04702841	CAR Malignant Tumor...	Chimeric antige...	14 Years - 70 Years	PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Spots Global Cancer Trial Database for γδt

Every month we try and update this database with for γδt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for γδt

Every month we try and update this database with for γδt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for γδt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.