Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05445011
Status:
RECRUITING
Last Update Posted:
2022-07-06
First Post:
2022-06-23
Brief Title:
Anti-FLT3 CAR-T Cell TAA05 Cell Injection in the Treatment of Relapsed Refractory Acute Myeloid Leukemia
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Safety and Efficacy of Anti-FLT3 CAR- T Cell TAA05 Cell Injection in the Treatment of Relapsed Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical trial of Anti-FLT3 CAR-T Cell TAA05 Cell Injection in the treatment of patients with relapsed refractory acute myeloid leukemia The purpose is to evaluate the safety and efficacy of anti-FLT3 CAR-T cells in patients with relapsed refractory acute myeloid leukemia
Detailed Description:
Acute myeloid leukemia AML is a hematological malignancy characterized by clonal proliferation of hematopoietic stem cells or progenitor cells AML is the most common type of leukemia in adults the 5-year survival rate is only 24 Moreover 40-50 of young patients and most elderly patients eventually suffered relapses
FMS-like tyrosine kinase 3 FLT3 is a member of the class III receptor tyrosine kinases mainly expressed on the cell surface of hematopoietic progenitor cells and plays an important role in normal hematopoiesis such as proliferation differentiation and survival The variable expression of FLT3 can be found on leukemia blasts from over 90 of AML patients Although about 30 of AML have FLT3 gene mutations the ectodomain of the FLT3 molecule is usually spared so that cellular immunotherapy against it has great therapeutic potential It is shown that FLT3 expression is detected in more than half of hematopoietic stem cell HSC and multipotent progenitor MPP cells on average while the average positive rate of lymphoid progenitor CLP cells is less than 20 Since the expression level of FLT3 on hematopoietic cells is not as high as CD33 and CD123 potential hematological toxicity has been supposed to be less obstructive to the development of FLT3-CAR-T Cell products Besides the expression of FLT3 is not found in other normal tissues And it is reported that FLT3 CAR T cells did not deplete CD34 HSCs and preserve HSC differentiation in the mice model Therefore conducting CAR-T cell therapy targeting the FLT3 molecule could be very promising in the clinical practice of treating AML TAA05 Cell Injection is a kind of FLT3-targeted CAR-T cell containing an optimized CD28 costimulatory domain which could help reduce the risk of toxic side effects This clinical trial aims to evaluate the safety and efficacy of TAA05 Cell Injection in patients with FLT3 positive AML
FMS-like tyrosine kinase 3 FLT3 is a member of the class III receptor tyrosine kinases mainly expressed on the cell surface of hematopoietic progenitor cells and plays an important role in normal hematopoiesis such as proliferation differentiation and survival The variable expression of FLT3 can be found on leukemia blasts from over 90 of AML patients Although about 30 of AML have FLT3 gene mutations the ectodomain of the FLT3 molecule is usually spared so that cellular immunotherapy against it has great therapeutic potential It is shown that FLT3 expression is detected in more than half of hematopoietic stem cell HSC and multipotent progenitor MPP cells on average while the average positive rate of lymphoid progenitor CLP cells is less than 20 Since the expression level of FLT3 on hematopoietic cells is not as high as CD33 and CD123 potential hematological toxicity has been supposed to be less obstructive to the development of FLT3-CAR-T Cell products Besides the expression of FLT3 is not found in other normal tissues And it is reported that FLT3 CAR T cells did not deplete CD34 HSCs and preserve HSC differentiation in the mice model Therefore conducting CAR-T cell therapy targeting the FLT3 molecule could be very promising in the clinical practice of treating AML TAA05 Cell Injection is a kind of FLT3-targeted CAR-T cell containing an optimized CD28 costimulatory domain which could help reduce the risk of toxic side effects This clinical trial aims to evaluate the safety and efficacy of TAA05 Cell Injection in patients with FLT3 positive 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