Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immune Globulin Intravenous (Human), 10%, Immune Globulin Subcutaneous (Human), 20% Solution.
- Who it may be relevant to
- Registry conditions: Hypogammaglobulinemia, Acquired. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Chimeric antigen receptor (CAR) T cells are patient-derived T cells engineered to express a fusion protein that directs them to target a tumor-associated antigen. The tumor-associated antigen CD19 is expressed on tumor cells in these conditions as well as on healthy cells of the B cell lineage. This results the "on-target off-tumor" effect of profound B cell depletion in these patients often with attendant hypogammaglobulinemia (HGG). Serious infections are common in this patient population and represent the main cause of non-relapse related mortality in CAR T cell treated patients.
Treatment of HGG with immunoglobulin replacement therapy (IRT) is a core component of infection prevention. Standard of care IRT can be administered intravenously (IVIG) or subcutaneously (SCIG). The proposed project will investigate frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in patients treated with CAR T-cell therapy who are treated with IVIG and SCIG.
Interventions
- Biological Immune Globulin Intravenous (Human), 10%
Intravenous immune globulin replacement - Biological Immune Globulin Subcutaneous (Human), 20% Solution
Subcutaneous immune globulin replacement
Primary outcome measures
- Time normalized rate of infections grade 3 or greater [Time frame: 40 weeks]
Secondary outcome measures (10)
- Time normalized rate of validated infections [Time frame: 40 weeks]
- Days on therapeutic antibiotics [Time frame: 40 weeks]
- Days missed work/school/unable to perform normal daily activities due to infections [Time frame: 40 weeks]
- Total number of days of hospitalizations due to infections [Time frame: 40 weeks]
- Geometric mean of IgG serum trough concentration [Time frame: 40 weeks]
- Mean TSQM9 [Time frame: 40 weeks]
- IRT-related adverse events [Time frame: 40 weeks]
- Hours of infusion clinic time required for IVIG administration [Time frame: 40 weeks]
- Mean total grams of immunoglobulin administered [Time frame: 40 weeks]
- Mean leukocyte counts at the last study visit [Time frame: 40 weeks]
Eligibility criteria
Inclusion criteria
- 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
- Ability to provide informed consent
Exclusion criteria
- 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)
- SCIG infusion in the prior 3 months.
- History of allergy or severe reactions to immune globulin productions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT06989541 · HREBA.CC-24-0422