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Recruiting

NCT Number: NCT07348055

A Study of GR1803 in Systemic Lupus Erythematosus

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

Recruiting

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Key information

Conditions

Systemic Lupus Erthematosus Auto Immune Disease Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Professor Li

CONTACT

021-027-84397521

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GR1803 injection

Biological

step-up dosing, Dose and frequency according to the protocol

Primary outcomes

  1. incidence of adverse event

    Time frame: 52 week

    incidence of adverse event

Secondary outcomes

  1. efficacy of GR1803

    Time frame: 52 week

    clinical response of SLE

Study contacts

Contact information is provided by the study sponsor or research team.

Nian

CONTACT

[email protected]

021-50805989-08324

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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