Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585345
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With RelapsedRefractory Acute Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With RelapsedRefractory Acute Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute leukemia is a malignant clonal disease of hematopoietic stem cells At present the treatment for acute leukemia is relatively limited and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation The prognosis of recurrent and refractory acute leukemia is poor and there is a lack of effective treatment plan CD7 is a specific target on the surface of T cells and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemiaThis is an open single-arm single-center prospective clinical study The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia
Detailed Description:
CD7 expression was determined by flow cytometry After the target was determined the subjects received the target dose of CD7 CAR-T from 1105 to 1108 kg Each subject will start with a low dose of 1105kg and if there are no significant side effects will be increased to the next dose until the maximum tolerated dose is reached A variety of adverse events including neurological events hematological events infections and secondary tumors will be collected from the time of infusion of CAR T cells to 24 months after infusion To understand the complete response rate CR and partial response rate PR at 3 months Recurrence rate progression-free survival PFS and overall survival OS after 1 to 5 years of CD7 CAR-T reinfusion The amount and duration of CD7 CAR-T in vivo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None