Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513429
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus SLE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on Evaluating the Efficacy and Safety of IM19 CAR-T Cell Therapy in Patients With Refractory Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The study is a single-arm open-label clinical trial intended to recruit 3 refractory SLE subjects who meet the inclusion and exclusion criteria The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1106kg CAR-T cells The primary endpoint is to evaluate the improvement in SLE disease activity SLEDAI-2K and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion Additionally the study aims to assess long-term efficacy specifically achieving the treatment endpoint of lupus low disease activity state LLDAS at 360 days post-infusion and long-term improvement in disease activity as measured by SLEDAI-2K at 360 days The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated The study plan includes five phases screening phase cell collection phase lymphodepletion pretreatment phase cell infusion phase and follow-up phase
Detailed Description:
None
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