The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia

Exclusion criteria

• ✕. Patients with congenital bone marrow failure syndromes.
• ✕. Patients with bone marrow reticulin staining ≥ Grade 2.
• ✕. Patients with paroxysmal nocturnal hemoglobinuria (PNH) clone ≥50% or with active hemolysis.
• ✕. Patients with clonal chromosomal abnormalities characteristic of myelodysplastic syndrome (MDS) (except +8, 20q-, and -Y).
• ✕. Presence of active bacterial, viral, or fungal infection within 2 weeks prior to the first administration of the investigational drug (excluding common cold and onychomycosis), or any other severe infection. Any anti-infective therapy for infections must be completed at least 2 weeks before the first dose. History of HIV infection or HIV antibody positive during screening; positive treponema pallidum antibody during screening; active pulmonary tuberculosis (evidenced by chest imaging or other relevant examinations within 3 months prior to first administration or during screening indicating active TB infection); active hepatitis during screening (positive hepatitis B surface antigen \[HBsAg\], or positive hepatitis B core antibody \[HBcAb\] with HBV DNA ≥30 IU/mL, or positive hepatitis C antibody \[HCV Ab\] with positive HCV RNA).
• ✕. Presence of active bleeding in the gastrointestinal tract, respiratory tract, central nervous system, or other sites.
• ✕. History of significant clinical diseases that, in the investigator's judgment, would pose a safety risk for the subject's participation or affect the evaluation of efficacy or safety if the disease/condition worsens during the study. Examples include:
• ✕.1 Cardiovascular disease: acute myocardial infarction or unstable angina within the past year, severe arrhythmias (such as frequent multifocal PVCs, ventricular tachycardia, ventricular fibrillation, etc.), congestive heart failure, arterial or venous thrombosis, NYHA Class III-IV cardiac function.