A Study of GR1803 in Systemic Lupus Erythematosus

Genrix (Shanghai) Biopharmaceutical

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Auto Immune Disease; Systemic Lupus Erthematosus

Treatments: Biological: GR1803 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07348055

GR1803-007

Details and patient eligibility

About

to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• comfirmed diagnosis of systemic lupus erythematosus
• SLEDAI-2K≥6分
• written informed consent and ability to comply with protocol requirements
• have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months

Exclusion criteria

• with unstable acute and chronic diseases
• active infection
• history of malignant tumor within 5 years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

GR1803 injection dose 1

Experimental group

Treatment:

Biological: GR1803 injection

GR1803 injection dose 2

Experimental group

Treatment:

Biological: GR1803 injection

GR1803 injection dose 3

Experimental group

Treatment:

Biological: GR1803 injection

GR1803 injection dose 4

Experimental group

Treatment:

Biological: GR1803 injection