Phase II Study of Isatuximab for Treating Immune Blood Cell Disorders After Stem Cell Transplant

Inclusion Criteria

• Must be 18 years or older.
• The disease for which the patient had a stem cell transplant must be in remission.
• Must have previously shown recovery of white blood cells and platelets after the transplant.
• Must be at least 45 days post-transplant.
• Must have been diagnosed with immune cytopenias, such as:
  • Autoimmune Hemolytic Anemia (AIHA): Low hemoglobin levels with specific test results.
  • Immune Thrombocytopenia (ITP): Low platelet count or need for platelet transfusions.
  • Pure Red Cell Aplasia (PRCA): Severe anemia with low reticulocyte count.
• Must have not fully responded to previous treatments, such as steroids or other medications.
• Must have a certain level of neutrophils in the blood.
• No active hepatitis infection.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
• Men must agree not to donate sperm and use contraception during and after the study.
• Must be able to provide informed consent.

Exclusion Criteria

• Relapse or progression of the disease for which the transplant was done.
• Anemia or low platelet count due to specific transplant-related conditions.
• Active graft-versus-host disease (GVHD) requiring treatment, unless controlled.
• Organ failure based on specific criteria.
• Pregnancy or unwillingness to use birth control.
• Known HIV or active hepatitis A, B, or C infection.
• Any uncontrolled medical condition that poses a risk or may interfere with the study.
• Allergy or intolerance to study drugs or components.
• Recent use of investigational drugs.
• On maintenance therapy post-transplant, unless agreed upon by the study team.
• Unable to consent or comply with study procedures.