Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

Exclusion Criteria

• •Clinical manifestations typical for cold agglutinin disease.
• •Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin \< 6 g/dL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.
• •Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.
• •Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab.
• •Changes in doses (\> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.
• •Evidence of hypogammaglobulinemia during screening (IgA \< 70 mg/dL, IgG \< 700 mg/dL, and/or IgM \< 40 mg/dL) and frequent and/or severe infections.
• •Women who are pregnant or breastfeeding.
• •History of malignancy except for the following:
• •* Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening.
• •* Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer.
• •* Adequately treated carcinoma in situ without current evidence of disease.
• •Congestive heart failure (left ventricular ejection fraction of \< 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan).
• •Participants with:
• •* Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA.
• •Note: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result.
• •Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result).
• •Note: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines.
• •Note: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible.
• •Seropositivity for or history of active viral infection with HIV.
• •Active systemic infection (including infection with SARS-CoV-2).
• •Participants in a severely immunocompromised state, per investigator's clinical assessment.
• •Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable).
• •Coagulation or platelet function abnormality.
• •An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months).
• •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• •Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment/enrollment (except for chronic toxicities \[≤ Grade 2\] not expected to resolve).
• •Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications.
• •Unwillingness to undergo transfusion with blood components.
• •Current use of prohibited medication as described in the protocol.
• •Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.