A Study of GR1803 in Systemic Lupus Erythematosus

NCT ID: NCT07348055

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-01

Brief Summary

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

Detailed Description

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Conditions

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Systemic Lupus Erthematosus Auto Immune Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GR1803 injection dose 1

Group Type EXPERIMENTAL

GR1803 injection

Intervention Type BIOLOGICAL

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

GR1803 injection dose 2

Group Type EXPERIMENTAL

GR1803 injection

Intervention Type BIOLOGICAL

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

GR1803 injection dose 3

Group Type EXPERIMENTAL

GR1803 injection

Intervention Type BIOLOGICAL

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

GR1803 injection dose 4

Group Type EXPERIMENTAL

GR1803 injection

Intervention Type BIOLOGICAL

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

Interventions

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GR1803 injection

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nian

Role: CONTACT

021-50805989-08324

Facility Contacts

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Professor Li

Role: primary

021-027-84397521

Other Identifiers

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GR1803-007

Identifier Type: -

Identifier Source: org_study_id

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