Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414135
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-06
Brief Title:
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
Sponsor:
Liangjing Lu
Organization:
RenJi Hospital
Study Overview
Official Title:
A Dose Ranging Study to Evaluate the Safety Tolerance Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel Relma-cel in Patients With RefractoryProgressive Systemic Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Relma-cel is a product containing CD19-CAR-transduced T cells The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis Efficacy will be explored too If enrolled participants will undergo leukapheresis lymphodepleting chemotherapy and administration of Relma-cel
Detailed Description:
None
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