Targeting B cells and plasma cells in lupus with a dual-action antibody

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase Ib, interventional study evaluating a recombinant bispecific antibody called F182112 that simultaneously binds CD3 and BCMA. The approach aims to direct the body's immune system to reduce B cells and plasma cells that express BCMA, potentially reducing autoantibody production in lupus. Eligible participants are adults 18–65 with SLE diagnosed for at least 12 weeks, who can provide informed consent. Exclusions include prior BCMA-targeted therapy or recent B-cell or plasma cell–depleting treatments. The trial is sponsored by Shandong New Time Pharmaceutical Co., with Renji Hospital and Shanghai Jiao Tong University School of Medicine as locations.

Why it matters

Who can join: the full rules

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);

Where it's running

• Renji Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Bao
• Email: baochunde_1678@126.com
• Phone: 13601689747

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Extension of enpatoran for cutaneous lupus symptoms

  This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.

  Recruiting Phase 3 EMD Serono · Troy, Michigan · NCT07840287

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Carotid ultrasound to guide prevention of heart disease in inflammatory rheumatic diseases

  In people with inflammatory rheumatic diseases like RA, PsA, AxSpA, or SLE who are at modest cardiovascular risk, a carotid ultrasound test is used to see if they should start stronger lipid-lowering therapy to prevent heart problems.

  Recruiting at 7 sites Phase 4 Instituto de Investigación Marqués de Valdecilla · Alicante, Alicante and 16 other locations · NCT07611747

• Periodontal Health in Rare Kidney Conditions and Controls

  This study tests how common periodontitis is in people with rare kidney disorders and compares it to CKD patients and people without kidney disease.

  Recruiting Institutul Clinic Fundeni · Bucharest · NCT07575347

• Anti-CD19/BCMA CAR‑NK cell therapy for refractory pediatric rheumatic diseases

  This trial will test a single injection of engineered CAR‑NK cells aimed at CD19 and BCMA to see if it is safe and helps children aged 5 and older whose rheumatic diseases have not responded to other treatments.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07490041

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.