Experimental drug F182112 tested against Hard-to-Treat blood disorder

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.