RecruitingPhase 1Phase 2NCT07348055

A Study of GR1803 in Systemic Lupus Erythematosus

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


Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Enrollment

44 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • 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 Criteria3

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

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Interventions

BIOLOGICALGR1803 injection

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


Locations(1)

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

Wuhan, Hubei, China

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NCT07348055


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