Universal CAR-T Cells Targeting AML
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|ClinicalTrials.gov Identifier: NCT05995041
Recruitment Status : Recruiting
First Posted : August 16, 2023
Last Update Posted : October 12, 2023
|Condition or disease
|Acute Myeloid Leukemia
|Biological: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that grow in the bone marrow and interferes with the generation of normal blood cells.Over the past years, several groups have demonstrated that CLL1, CD33, CD38 and CD123 are potential AML targets. CLL-1 (C-type lectin-like molecule-1) is a transmembrane glycoprotein, which is overexpressed in leukemic stem cells but absent in normal hematopoietic stem cells, suggesting that CLL-1 can be a promising target for targeted AML therapy. Although CAR-T cells have shown impressive anti-leukemic effect in B cell disease, CAR-T treatment for AML has proven to be more difficult. One of the reasons is because AML patients often has highly suppressed bone marrow function, and it is often difficult to obtain good quality of T cells for CAR-T preparation. In addition, AML progression can be acute and rapid, which can outpace the CAR-T expansion, and the time-consuming CAR-T manufacture process makes it more difficult to treat AML with autologous source of T cells By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients with short disease remission time under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells.
The purpose of this study is to assess the feasibility, safety and efficacy of several AML-specific universal CAR-T products. Another goal is to learn more about the function of the universal CAR T cells and their persistency in the patients.
|Study Type :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|Single Group Assignment
|None (Open Label)
|Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia
|Estimated Study Start Date :
|October 31, 2023
|Estimated Primary Completion Date :
|September 30, 2026
|Estimated Study Completion Date :
|December 31, 2026
|Experimental: Multiple universal CAR T cells to treat AML
Biological: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells
- Safety of infusion [ Time Frame: 6 months ]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): NCT05995041
|Contact: Lung-Ji Chang, Ph.D
|Contact: Ying Deng
|Shenzhen Geno-Immune Medical Institute
|Shenzhen, Guangdong, China, 518000
|Contact: Lung-Ji Chang, Ph.D 86-0755-8672 5195 firstname.lastname@example.org