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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Shandong New Time Pharmaceutical Co., LTD • ClinicalTrials.gov ID: NCT07829614

Registry updated: 2026-09-21
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Description

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.

Interventions

  • F182112 (Drug)
    F182112 Dose Escalation and Dose Expansion

Eligibility criteria

Inclusion Criteria: 1. Age 18-65 years, any gender; 2. 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); 3. Able to understand the trial procedures and content, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Previously received BCMA-targeted therapy; 2. 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);

Conditions

Systemic Lupus Erythematosus (SLE)

Locations

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record