Study on GD2 Positive Solid Tumors by 4SCAR-GD2
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|ClinicalTrials.gov Identifier: NCT02992210|
Recruitment Status : Unknown
Verified February 2018 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was: Recruiting
First Posted : December 14, 2016
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Genetic: 4SCAR-GD2||Phase 1 Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Trial of Phase I/II Studies on GD2 Positive Solid Tumors by 4SCAR-GD2|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: effectiveness of 4SCAR-GD2 T cells
The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognize of GD2 .This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and recurrent solid tumors
Other Name: GD2-specific 4th Generation CART
- Number of patients with adverse events. [ Time Frame: 3 year ]Determine the toxicity profile the 4SCAR-GD2-modified T cells with Common Toxicity Criteria for Adverse Effects version 4.0
- Anti-tumor effects [ Time Frame: 3 year ]Disease status is defined by the biochemical markers and image scan to get the outcomes such as Complete response/remission (CR) , Very good partial response/remission (VGPR) , etc
- The expansion and persistence of anti-GD2 CAR T cells [ Time Frame: 3 year ]The investigators will monitor the expansion and functional persistence of 4SCAR-GD2 T cells in the peripheral blood of patients and the correlation with antitumor effects
- Immune responses after anti-GD2 infusions [ Time Frame: 1 year ]assessment of lymphocyte phenotypes and anti-tumor activity
- Immune responses after anti-GD2 infusions [ Time Frame: 1 year ]assessment of cytokine profile
- Survival time of the patients [ Time Frame: 3 year ]Evaluate the survival time of the patients treated with the 4SCAR-GD2 T cells, including progression free survival (PFS) and overall survival (OS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992210
|Contact: Lung-Ji Chang, PhD.||+firstname.lastname@example.org|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD +86-13671121909 email@example.com|
|Principal Investigator:||Lung-Ji Chang||Shenzhen Geno-Immune Medical Institute|