Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530849
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 Clinical Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 single-arm open-label multicenter phase 12 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus SLE
Detailed Description:
This is a single-arm open-label multicenter phase 12 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory SLEThe dose-escalation phase 1 study aims to assess the safety of GC012F Injection and determine the Recommended Phase II Dose RP2D The phase 2 study aims to determine the efficacy and safety of GC012F Injection at the RP2D in patients with refractory SLE and assess the pharmacokinetics PK and pharmacodynamics PD characteristics
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