Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641024
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed Refractory B-ALL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte MC-1-50 for the Treatment of RelapsedRefractory CD19-positive B-cell Acute Lymphoblastic Leukemia B-ALL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This is a single-arm open-label dose-escalation phase I clinical study to explore the safety tolerability and cytokinetic characteristics of MC-1-50 cell formulation and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsedrefractory CD19-positive B Cell Acute Lymphoblastic Leukemia
Detailed Description:
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform the cell preparation time is about 3 days which can greatly shorten the waiting time of patients improve production efficiency and reduce production costs At the same time MC-1-50 products have a high proportion of T naive cells which can play a therapeutic effect at a very low infusion dose to improve safety In this study a 343334 design was adopted and three dose groups were set up with 1105kg 3105kg and 5105kg CAR-positive cells respectively the upper limit of the total number of cells was not more than 5107 CAR-positive cells All subjects received only one infusion of MC-1-50 cells
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