Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05017883
Status:
RECRUITING
Last Update Posted:
2021-11-04
First Post:
2021-08-17
Brief Title:
TAA05 Cell Injection in the Treatment of Recurrent Refractory Acute Myeloid Leukemia
Sponsor:
PersonGen BioTherapeutics Suzhou Co Ltd
Organization:
PersonGen BioTherapeutics Suzhou Co Ltd
Study Overview
Official Title:
TAA05 Cell Injection in the Treatment of Recurrent Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2021-08
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 study of ytaa05 cell injection in the treatment of patients with recurrent refractory acute myeloid leukemiaThe purpose is to evaluate the safety and preliminary efficacy of FLT3 car-t cells in patients with recurrent refractory FLT3 positive acute myeloid leukemiaTAA05 cell injection is a T cell targeting FLT3 chimeric antigen receptor
Detailed Description:
Acute myeloid leukemia AML is a hematological malignancy caused by abnormal differentiation and uncontrolled proliferation of hematopoietic progenitor cells If AML is not given active treatment within one year after diagnosis it will cause fatal infection bleeding and organ infiltration due to abnormal proliferation of tumor cells AML is one of the most common leukemia About 38 patients in every 100000 people are in the higher incidence rate among people aged 65 and over and 179 patients in every 100000 people The cure rate of AML is about 35-40 in patients 60 years old and only 5-15 in patients over 60 years old The survival of elderly patients who can not tolerate chemotherapy is frustrating and the median survival time is only 5-10 months In the past 20 to 30 years the treatment of acute myeloid leukemia AML has made significant progress so that about 80 of adult patients under the age of 55 can achieve complete remission However more than half of Cr patients will relapse and the long-term survival rate is about 40 Until the 1970s diagnosis was only based on pathological and cytological examination of bone marrow and blood The five-year survival rate was less than 15
CAR-T cells can recognize specific antigens in a non restricted manner of HLA and continuously activate T cells FLT3 is a potential target of AML Therefore the construction of car-t cells that recognize human FLT3 molecule has high clinical value in the treatment of AML
CAR-T cells can recognize specific antigens in a non restricted manner of HLA and continuously activate T cells FLT3 is a potential target of AML Therefore the construction of car-t cells that recognize human FLT3 molecule has high clinical value in the treatment of 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