Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653556
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
A Study of LCAR-AIO in Subjects with RelapsedRefractory Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of LCAR-AIO for the Treatment of RelapsedRefractory Systemic Lupus Erythematosus rr SLE
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 prospective single-arm open-label dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsedrefractory systemic lupus erythematosus
Detailed Description:
This is a prospective single-arm open-label exploratory clinical study to evaluate the safety tolerability pharmacokinetics and efficacy profiles of LCAR-AIO a chimeric antigen receptor CAR -T cell therapy in subjects with relapsedrefractory systemic lupus erythematosus Patients who meet the eligibility criteria will receive LCAR-AIO infusion The study will include the following sequential stages screening apheresis pre-treatment cell product preparation lymphodepleting chemotherapy treatment LCAR AIO infusion and follow-up
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