F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus

The investigational drug is an injectable recombinant humanized anti-BCMA/CD3 bispecific antibody (code: F182112) that can simultaneously target the immune effector cell antigen CD3 and the antigen BCMA. Through a dual-targeting mechanism, it aims to guide the body's own immune system to target and kill B cells and plasma cells that overexpress BCMA.Based on the application of B cell depletion strategies in the treatment of autoimmune diseases, as well as the exploration of similar drugs in autoimmune diseases, we speculate that F182112 is also effective for autoimmune diseases. Therefore, we plan to carry out clinical research of F182112 in patients with systemic lupus erythematosus, with the aim of bringing more treatment options to patients.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18-65 years, any gender;
Diagnosed with systemic lupus erythematosus (SLE) ≥12 weeks according to the classification criteria established by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR);
Able to understand the trial procedures and content, and voluntarily sign the informed consent form.

Exclusion criteria

Previously received BCMA-targeted therapy;
Received any B-cell depletion therapy (such as anti-CD20, anti-CD19, etc.) or anti-plasma cell therapy within 6 months before starting the drug or within 5 half-lives (whichever is longer);

Treatment and study plan

F182112

Drug

F182112 Dose Escalation and Dose Expansion

Primary outcomes

The Incidence of Adverse Events (AE), Serious Adverse Events (SAE)

Time frame: During the period of dose-limiting toxicity observation (within 28 days after the first administration)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Shandong New Time Pharmaceutical Co., LTD

Industry

Registry information

Official study title

Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Sep 21, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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