Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia

Inclusion criteria

• 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.
• Participants and their partners agree to use effective contraception from informed consent through 1 year after study treatment.
• Written informed consent must be obtained before any study-specific screening procedures.

Exclusion criteria

• 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.
• New thrombotic events or organ infarction within 6 months before enrollment.
• Prior BCMA-targeted therapy within 6 months before enrollment.
• Any of the following prior treatments within the specified washout periods: Anti-CD20 monoclonal antibody within 12 weeks; Sutimlimab or other approved biologic therapy within 5 half-lives; Plasma exchange within 4 weeks; Splenectomy within 12 weeks.
• Any of the following cardiovascular conditions: LVEF ≤45%; Active cardiac disease or NYHA class III/IV heart failure; Clinically significant arrhythmia requiring treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia; QTc ≥450 ms in males or ≥470 ms in females; Myocardial infarction, coronary artery bypass grafting, or coronary stent placement within 6 months; Other clinically significant cardiac disease considered unsuitable by the investigator.
• Unstable systemic disease, including severe hepatic or renal disease requiring treatment.
• History of another primary malignancy within 5 years before screening, except adequately treated non-melanoma skin cancer, carcinoma in situ, or other malignancies without recurrence for ≥5 years.
• Major surgery within 4 weeks before screening if considered unsuitable for enrollment by the investigator.
• Uncontrolled active fungal, viral, bacterial, tuberculosis, or other infection, or infection requiring intravenous antimicrobial therapy.
• Active or clinically significant HBV, HCV, HIV, or syphilis infection
• Live-virus vaccination within 4 weeks before enrollment.
• Participation in another interventional clinical study within 5 half-lives of the investigational treatment before screening, or planned use of another investigational treatment during this study.
• Pregnant or breastfeeding women.
• Psychiatric disorders, impaired consciousness, or central nervous system disorders, including a history of epilepsy or Parkinson's disease.
• Known hypersensitivity to any component of F182112.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.