NCT07829614RecruitingPhase 1
F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus
Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 30 Oct 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Diseases
- Lupus (SLE)
- NCT number
- NCT07829614
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 64
- From 30 Oct 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.