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

NCT07829614 · tracked via the Priya Life Science China tracker

Sponsor

Shandong New Time Pharmaceutical Co., LTD

Phase

Phase 1

Started

2025-10-30

Last updated

2026-09-21

Condition(s) studied

Systemic Lupus Erythematosus (SLE)

Investigational drug(s) / intervention(s)

F182112

F182112: F182112 Dose Escalation and Dose Expansion

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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);

Primary outcome measure(s)

The Incidence of Adverse Events (AE), Serious Adverse Events (SAE) — During the period of dose-limiting toxicity observation (within 28 days after the first administration)

Trial sites (1)

Facility	City	Region	Status
Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07829614 on ClinicalTrials.gov ↗ ← All trials in China