Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05739409
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-12
Brief Title:
LILRB4 STAR-T Cell Therapy for Monocytic Leukemia
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Monocytic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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 single-centersingle-armopen-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in Monocytic Leukemia subjects
Detailed Description:
This study will recruit LILRB4-positive monocytic leukemia subjects who will receive cyclophosphamide and fludarabine on days -5 to -3 prior to cell infusion followed by LILRB4 STAR-T cells The primary objective of the study was to evaluate the safety and tolerability of LILRB4 STAR-T cells in subjects with monocytic leukemia The secondary objective was to evaluate the therapeutic efficacy pharmacodynamics and pharmacokinetics of LILRB4 STAR-T cells
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