A Study of GR1803 in Systemic Lupus Erythematosus

March 9, 2026 updated by: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Professor Li
          • Phone Number: 021-027-84397521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GR1803 injection dose 1
Biological: GR1803 injection
step-up dosing, Dose and frequency according to the protocol
Experimental: GR1803 injection dose 2
Biological: GR1803 injection
step-up dosing, Dose and frequency according to the protocol
Experimental: GR1803 injection dose 3
Biological: GR1803 injection
step-up dosing, Dose and frequency according to the protocol
Experimental: GR1803 injection dose 4
Biological: GR1803 injection
step-up dosing, Dose and frequency according to the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of adverse event
Time Frame: 52 week
incidence of adverse event
52 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of GR1803
Time Frame: 52 week
clinical response of SLE
52 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR1803-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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