This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.
Age 18-75 years.
Diagnosis of AIHA according to established Chinese or international criteria, including warm AIHA, mixed AIHA, cold agglutinin disease, or Evans syndrome.
Refractory to multiple lines of therapy, meeting all of the following: HGB <100 g/L with evidence of hemolytic anemia; Prior treatment with ≥2 immunosuppressive therapies, including a CD20 monoclonal antibody; Glucocorticoid treatment for ≥3 months, unless contraindicated or intolerable; Adequate prior CD20 monoclonal antibody treatment (≥4 doses of 100 mg or 375 mg/m², or 2 doses of 1,000 mg).
ECOG performance status ≤2.
Diagnosed lymphoproliferative malignancy.
Secondary AIHA caused by drugs or infection.
Congenital immunodeficiency or other inherited or acquired hemolytic disorders.
Prior organ or hematopoietic stem cell transplantation.
Single group
F182112 single-agent
DrugThe dose-escalation phase will evaluate three sequential target dose levels of F182112: 30 μg/kg, 90 μg/kg, and 180 μg/kg, using a standard 3+3 design. F182112 will be administered intravenously using a priming dose followed by a target dose.
Incidence of adverse events
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event
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