NCT06530849

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

A Phase 1/2 Clinical Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Gracell Biotechnologies (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Refractory Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	GC012F Injection	GC012F Injection is an autologous chimeric antigen receptor T cell therapy targeting both BCMA and CD19

Timeline

• Start date: 2024-08-22
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-07-31
• Last updated: 2026-04-08

Locations

2 sites across 1 country: China