Multiple CAR-T Cell Therapy Targeting AML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04010877|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cells||Phase 1 Phase 2|
Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that grow in the bone marrow and interfere with the generation of normal blood cells.
Over the past few years, several groups have demonstrated that CD33 and CD123 CAR T cells can eradicate AML in both preclinical and clinical trials. Nevertheless, relapse after CAR T therapy remains a critical problem in treating AML. Disease relapse can be caused by antigen escape and by the outgrowth of residual leukemia stem cells (LSCs) that are not effectively eliminated by CAR T cells. CLL-1 (C-type lectin-like molecule-1) is a transmembrane glycoprotein, which is overexpressed in LSCs but absent in HSCs (hematopoietic stem cells), suggesting that CLL-1 might be a promising target for novel AML therapy. In this study, we use CLL-1 CAR-T in combination with CD123 and/or CD33 CAR-T as a new strategy to address LSC issue and prevent relapse caused by antigen escape.
The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize specific molecules (CD33, CD123 or CLL-1) expressed on the surface of AML cells. The engineered T cells will be applied to patients through intravenous delivery.
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple CAR-T cell therapy in AML. Another goal of the study is to learn more about the function of CAR T cells and their persistency in the patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center Phase I/II Clinical Trial of Multiple CAR T Cells for Treating Acute Myeloid Leukemia|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Multiple CAR T cells to treat AML
Multiple CAR T cells to treat AML
Biological: CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cells
Infusion of CLL-1, CD33 and/or CD123-specific CAR-T cells
- Safety of infusion [ Time Frame: 1 year ]Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
- Clinical response [ Time Frame: 1 year ]Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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): NCT04010877
|Contact: Lung-Ji Chang, Ph.Demail@example.com|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Principal Investigator:||Lung-Ji Chang, Ph.D||Shenzhen Geno-Immune Medical Institute|