drugset / Trial / NCT07829614

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

NCT07829614 ↗

Phase 1 Recruiting 64 enrolled Shandong New Time Pharmaceutical Co., LTD
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-30
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject F182112 Monoclonal antibody — —