Chimeric antigen receptor (CAR) T cells are special immune cells taken from a patient and changed in a lab to help them find and attack cancer cells. These cells are designed to look for a marker called CD19, which is found on both cancer cells and healthy B cells (a type of white blood cell). Because of this, CAR T cells can also destroy healthy B cells. This can lead to a strong drop in B cells and cause a condition called hypogammaglobulinemia (HGG), which makes it harder for the body to fight infections. Serious infections are common in people treated with CAR T cells and are a major reason for death that is not caused by the return of cancer.
To help prevent infections, patients with HGG often get immunoglobulin replacement therapy (IRT), which gives them the antibodies they need. This treatment can be given through a vein (IVIG) or under the skin (SCIG). The goal of this project is to study how often these patients get bacterial infections, how they feel about their quality of life and treatment, and what side effects they may have when treated with IVIG or SCIG after CAR T-cell therapy.
Age ≥18 years
Severe HGG defined as total IgG <4 g/L (after subtracting the IgG paraprotein fraction, if present)
Treated with CD19 targeted CAR T cell therapy in the past 6 months
Consent to receive plasma-derived productions
Inability to comply with study procedures
Pregnancy or planning to conceive
Breastfeeding
Protein-losing conditions that may contribute to HGG (e.g., protein-losing enteropathy, nephrotic syndrome)
Patients treated with CD19 targeted CAR T cell therapy for B cell malignancy
Cohort
Prospective
Immune Globulin Intravenous (Human), 10%
Biological/VaccineIntravenous immune globulin replacement
Immune Globulin Subcutaneous (Human), 20% Solution
Biological/VaccineSubcutaneous immune globulin replacement
Time normalized rate of infections grade 3 or greater
Time normalized rate of infections grade 3 or greater
Time normalized rate of validated infections
Time normalized rate of infections (per subject-year) confirmed using microbiologic, clinical, and radiologic criteria
Days on therapeutic antibiotics
Days on therapeutic antibiotics for treatment of an infection (excluding days on routinely provided prophylactic antibiotics)
Days missed work/school/unable to perform normal daily activities due to infections
Days missed work/school/unable to perform normal daily activities due to infections (rate per subject-year)
Total number of days of hospitalizations due to infections
Total number of days of hospitalizations due to infections (rate per subject-year)
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