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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07348055

Enrollment

Registered

2026-01-16

Start date

2026-02-02

Completion date

2027-12-01

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto Immune Disease, Systemic Lupus Erthematosus

Keywords

BCMA/CD3 Bispecific Antibody, systemic lupus erythematosus

Brief summary

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

Interventions

BIOLOGICALGR1803 injection

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
incidence of adverse event	52 week	incidence of adverse event

Secondary

Measure	Time frame	Description
efficacy of GR1803	52 week	clinical response of SLE

Countries

China

Contacts

CONTACTNian

nianhanli@genrixbio.com021-50805989-08324

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026