Ignite Creation Date:
2025-12-18 @ 9:08 AM
Ignite Modification Date:
2025-12-18 @ 9:08 AM
Study NCT ID:
NCT06530849
Status:
None
Last Update Posted:
2025-10-14 00:00:00
First Post:
2024-07-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 1/2 Clinical Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
Status:
None
Status Verified Date:
2025-10
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 a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory SLE；The 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.
Detailed Description:
None
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?: