Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544330
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Autologous CD19 CAR-T Cell Therapy SYNCAR-001 Orthogonal IL-2 STK-009 in Subjects With Severe Refractory Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy SYNCAR-001 STK-009 in Subjects With Severe Refractory Systemic Lupus Erythematosus
Status:
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:
This is a phase 1 study of SYNCAR-001 STK-009 in patients with severe refractory systemic lupus erythematosus
Detailed Description:
SYNCAR-001 STK-009 is a 2-component human orthogonal ho IL-2 receptor-ligand cell therapy consisting of 1 SYNCAR-001 a CD19-directed chimeric antigen receptor T cell CAR-T co-expressing an engineered IL-2 beta receptor hoRb and 2 STK-009 an engineered pegylated IL-2 cytokine hoIL-2 selective for hoRb This study is being conducted to evaluate the safety and efficacy of a single dose of SYNCAR-001 followed by multiple subcutaneously administered doses of STK-009 No conditioning chemotherapy lymphodepletion will be administered The study will follow a 33 design during dose escalation followed by dose expansion at the recommended phase 2 dose RP2D
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