Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585514
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-Label Non-Randomized Single-Arm Phase 12 Study of Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus SLE
Detailed Description:
This is a single-center open-label non-randomized Phase III trial Patients with refractory systemic lupus erythematosus SLE will receive CD19 CAR T cells The primary objective is to learn about the safety and tolerability of CD19 CAR T cell therapy in subjects with refractory SLE and to determine the optimal biological dose OBD and recommend phase 2 dose RP2D in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with refractory SLE in phase II The primary endpoint is type and incidence of dose limiting toxicity DLT within 28 days after CD19 CAR T-cell infusion in phase I and overall response rate ORR in phase II A total number of 18 subjects will be enrolled
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