Clinical Trial

A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
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 Systemic Lupus Erythematosus (SLE).
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-10
notable Enrollment reduced: 118 -> 20 participants 2026-06-10
critical Phase changed: Phase 1 -> Phase 1/2 2026-04-09
notable Enrollment increased: 18 -> 118 participants 2026-04-09
Trial Details
NCT Number NCT06530849
Lead Sponsor Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborators: AstraZeneca, Suzhou Gracell Biotechnologies Co., Ltd.
Conditions Refractory Systemic Lupus Erythematosus
Enrollment 20 participants
Start Date 2024-08-22
Primary Completion 2027-02-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09