Phase Ib Clinical Study Evaluating the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Immunogenicity of F182112 in Patients With Systemic Lupus Erythematosus
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- The Incidence of Adverse Events (AE), Serious Adverse Events (SAE)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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);
Arms & Interventions
F182112 Phase Ⅰb Clinical Study in the Treatment of Patients with Systemic Lupus Erythematosus
Intervention: F182112 (Drug)
Outcomes
Primary Outcomes
The Incidence of Adverse Events (AE), Serious Adverse Events (SAE)
Time Frame: During the period of dose-limiting toxicity observation (within 28 days after the first administration)
Secondary Outcomes
No secondary outcomes reported