NCT07348055

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
19mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 25, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

December 25, 2025

Last Update Submit

March 9, 2026

Conditions

Auto Immune DiseaseSystemic Lupus Erthematosus

Keywords

BCMA/CD3 Bispecific Antibodysystemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

  • incidence of adverse event

    incidence of adverse event

    52 week

Secondary Outcomes (1)

  • efficacy of GR1803

    52 week

Study Arms (4)

GR1803 injection dose 1

EXPERIMENTAL
Biological: GR1803 injection

GR1803 injection dose 2

EXPERIMENTAL
Biological: GR1803 injection

GR1803 injection dose 3

EXPERIMENTAL
Biological: GR1803 injection

GR1803 injection dose 4

EXPERIMENTAL
Biological: GR1803 injection

Interventions

GR1803 injectionBIOLOGICAL

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

GR1803 injection dose 1GR1803 injection dose 2GR1803 injection dose 3GR1803 injection dose 4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Nian

CONTACT

021-50805989-08324nianhanli@genrixbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 16, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

CN(1)