Study on GD2 Positive Solid Tumors by 4SCAR-GD2

Solid Tumor Clinical Trial

Official title: Multicenter Trial of Phase I/II Studies on GD2 Positive Solid Tumors by 4SCAR-GD2

Status Recruiting

Clinical Trial Summary

Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognition of GD2, a surface protein expressed at high levels on many types of tumors but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.

Clinical Trial Description

Background:

Patients with refractory and/or recurrent solid tumors have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a 4th generation GD2-specific chimeric antigen receptor (4SCAR-GD2). The chimeric antigen receptor (CAR) molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, GD2, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. This study will evaluate the side effects and the best dose of a novel 4th generation anti-GD2 CAR T cells to refractory and/or recurrent solid tumors.

Design:

Participants will be screened through physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow aspirates may be performed.

Peripheral blood mononuclear cells (PBMC) will be obtained by apheresis, and T cells will be activated and modified to express the 4SCAR-GD2 gene.

On Day -5 to -7, PBMC will be activated and enriched for T cells, which will be followed by 4SCAR-GD2 lentiviral transduction. The total culture time is approximately 5-7 days.

Participants will receive a preparative conditioning regimen comprising cyclophosphamide/fludarabine to prepare their immune system to accept the modified CAR T cells.The preparative regimen will be based on patient immune condition and consistent with standard chemotherapy conditioning regimen. ;

Related Conditions & MeSH terms

• Solid Tumor

• NCT number: NCT02992210
• Study type: Interventional
• Source: Shenzhen Geno-Immune Medical Institute
• Contact: Lung-Ji Chang, PhD.
• Phone: +86-8672-5195
• Email: c@szgimi.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Completion date: December 2020