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NCT04991532 Clinical Trial

Dasatinib Down-regulates the Expression of PD-1 and Enhances Killing pH + Leukemia Stem Cells

Chronic Myeloid Leukemia Clinical Trial

Official title:
Research on the Mechanism of Dasatinib Down-regulates the Expression of PD-1 in CMV-activated NKG2C+NK Cells and Enhances Killing pH + Leukemia Stem Cells.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04991532
Other study ID # NFEC-2021-130
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 20, 2021
Est. completion date December 2022

Study information
Verified date August 2021
Source Nanfang Hospital of Southern Medical University
Contact Dan Xu
Phone +86-20-61641615
Email 522111156@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Research on the mechanism of dasatinib down-regulates the expression of PD-1 in CMV-activated NKG2C+NK cells and enhances killing pH + leukemia stem cells.

Description:

Some patients with CML can withdraw from TKIs after treatment, and the mechanism might be related to the effect of memory NK cells on anti-Ph+ leukemic stem cells (LSCs). Dasatinib affects immune through several pathways including the expression of PD1 in immune cells. Our previous work showed increased NKG2C+ NK cells were found in cases with CMV-DNA+ who suffered Ph+ leukemia and received Dasatinib, and these memory NK cells have anti-LSCs activity. We hypothesize that: CMV infection activates NKG2C+ memory NK cells proliferation; Dasatinib down-regulates the expression of PD1 in PD1+NKG2C+ NK cell subsets and then enhances anti-LSCs activity of these cells. In this study, the effect of Dasatinib on CMV-activated NKG2C+ cell subsets and its mechanism will be studies. Besides, the different NKG2C+ cell subsets on LSCs will be compared. This study might be helpful to clarify the mechanism of TKI withdrawal and to offer foundation for CMV and Ph+ ALL treatment strategies

Recruitment information / eligibility
Status Recruiting
Enrollment 324
Est. completion date December 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age >18 years old, gender is not limited 2. CML-CP patients treated with TKIs 3. No pregnancy was planned during the treatment Exclusion Criteria: 1.The researcher judged that it was not suitable to participate in this study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years 2 years
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