Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03473457
Status:
TERMINATED
Last Update Posted:
2021-09-13
First Post:
2018-03-15
Brief Title:
CAR-T Cells Therapy in RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
The Prospective Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor TCAR-T Cells Therapy in RelapsedRefractory Acute Myeloid Leukemia
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The therapeutic effect was not as expected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AML
Brief Summary:
Acute myeloid leukemia AML is a group of genetically highly heterogeneous malignant disease The disease is the most common type of adult acute leukemia Overall survival OS was less than 50 in 5 years Chimeric Antigen Receptor-transduced T cell CAR-T therapy is one of revolutionary targeted immunotherapy The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized although it start late several clinical trials have been register in ClinicalTrialsgov
Detailed Description:
Acute myeloid leukemia AML is a group of genetically highly heterogeneous malignant disease its character is immature myeloid protocel abnormal differentiation and proliferation in the bone marrow The disease is the most common type of adult acute leukemia Overall survival OS was less than 50 in 5 years Chimeric Antigen Receptor-transduced T cell CAR-T therapy is one of revolutionary targeted immunotherapy
CAR - T cells are taken in the form of genetic modification and specific identified target antigen monoclonal antibody of single variable region scFv expression in T cell surface and coupled with the activation of intracellular proliferation signal domainWhen scFv recognizes antigens expressed in malignant cells it stimulates the activation signal of downstream T cells and produces specific killing effects CAR-T therapy is one of revolutionary targeted immunotherapyThe efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized although it start late several clinical trials have been register in ClinicalTrialsgov
The cluster of differentiation CD antigen serves as the target for identification and research in the immuno-phenotype detection of cellsAs the surface markers of immune typing CD molecules can be used as cell identification for expression types and levels on the cell surfaceCell surface of AML has a specific type of CD molecule expressionsuch as cluster of differentiation antigen 33CD33cluster of differentiation 38CD38cluster of differentiation 56 CD56 cluster of differentiation 123CD123 cluster of differentiation 117CD117 cluster of differentiation 133CD133 cluster of differentiation 34CD34 and MuclTherefore it provides some good targets for the immunotherapy of CAR T cellsIn AML cells and mouse modelsome studies have confirmed anti-CD33 CAR-T and anti-CD123 CAR-T with good similar lethality but the toxicity of CAR-T to myeloid hematopoietic stemprogenitor cells and mononuclear cells is widespreadIn comparisonCD123 CAR-T Off-target effects slighter than CD33 CAR-T
In order to lay a foundation for the application of relapsedrefractory AML patients with CAR-T therapyobjects are refractory relapsed patients with AMLand plans to into the group of the number of cases in 50 casesThe main content is safety efficacy and feasibility analysis of the CAR-T cells single CAR-T or double CAR-T cells with CD33CD38CD56CD123CD117CD133CD34 or Mucl in the treatment of refractoryrelapsed AML
CAR - T cells are taken in the form of genetic modification and specific identified target antigen monoclonal antibody of single variable region scFv expression in T cell surface and coupled with the activation of intracellular proliferation signal domainWhen scFv recognizes antigens expressed in malignant cells it stimulates the activation signal of downstream T cells and produces specific killing effects CAR-T therapy is one of revolutionary targeted immunotherapyThe efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized although it start late several clinical trials have been register in ClinicalTrialsgov
The cluster of differentiation CD antigen serves as the target for identification and research in the immuno-phenotype detection of cellsAs the surface markers of immune typing CD molecules can be used as cell identification for expression types and levels on the cell surfaceCell surface of AML has a specific type of CD molecule expressionsuch as cluster of differentiation antigen 33CD33cluster of differentiation 38CD38cluster of differentiation 56 CD56 cluster of differentiation 123CD123 cluster of differentiation 117CD117 cluster of differentiation 133CD133 cluster of differentiation 34CD34 and MuclTherefore it provides some good targets for the immunotherapy of CAR T cellsIn AML cells and mouse modelsome studies have confirmed anti-CD33 CAR-T and anti-CD123 CAR-T with good similar lethality but the toxicity of CAR-T to myeloid hematopoietic stemprogenitor cells and mononuclear cells is widespreadIn comparisonCD123 CAR-T Off-target effects slighter than CD33 CAR-T
In order to lay a foundation for the application of relapsedrefractory AML patients with CAR-T therapyobjects are refractory relapsed patients with AMLand plans to into the group of the number of cases in 50 casesThe main content is safety efficacy and feasibility analysis of the CAR-T cells single CAR-T or double CAR-T cells with CD33CD38CD56CD123CD117CD133CD34 or Mucl in the treatment of refractoryrelapsed AML
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None