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F182112 Phase Ib Clinical Study for the Treatment of Patients With Systemic Lupus Erythematosus
Sponsor: Shandong New Time Pharmaceutical Co., LTD
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.
Official title: Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2025-10-30
Completion Date
2027-12-31
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
F182112
F182112 Dose Escalation and Dose Expansion
Locations (1)
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China