Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462144
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-04
Brief Title:
IMPT-514 in Systemic Lupus Erythematosus Anca-associated Vasculitis and Idiopathic Inflammatory Myopathy
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
An Exploartory Trial of IMPT-514 An Autologous Anti-CD1920 CAR T Therapy in Participants With Active Refractory Systemic Lupus Erythematosus Anca-associated Vasculitis and Idiopathic Inflammatory Myopathy
Status:
RECRUITING
Status Verified Date:
2024-07
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 an exploratory trial to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of a single dose of IMPT-514 an autologous anti-CD19CD20 CAR T therapy administered as an intravenous IV infusion in participants with B cell driven autoimmune diseases including active refractory Systemic Lupus Erythematosus SLE ANCA Associated Vasculitis AAV and Idiopathic Inflammatory Myopathy IIM
Detailed Description:
This study will explore the safety of IMPT-514 and will include up to two dose levels with up to 12 total expected dosed participants for each disease group of SLE AAV and IIM
IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide Individual participants will remain in the active post-treatment period for approximately 2 year from IMPT-415 administration
IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide Individual participants will remain in the active post-treatment period for approximately 2 year from IMPT-415 administration
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