An observational study in Hypogammaglobulinemia, Acquired, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Alberta · Observational
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.
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.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's planned enrollment of 30 is below the median of 119 across 13 observational studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Patients treated with CD19 targeted CAR T cell therapy for B cell malignancy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous Immunoglobulin Replacement
Biological: Immune Globulin Intravenous (Human), 10%
Subcutaneous Immunoglobulin Replacement
Biological: Immune Globulin Subcutaneous (Human), 20% Solution
Intravenous immune globulin replacement
Subcutaneous immune globulin replacement
Time normalized rate of infections grade 3 or greater
Time normalized rate of infections grade 3 or greater
Time frame: 40 weeks
Time normalized rate of validated infections
Time normalized rate of infections (per subject-year) confirmed using microbiologic, clinical, and radiologic criteria
Time frame: 40 weeks
Days on therapeutic antibiotics
Days on therapeutic antibiotics for treatment of an infection (excluding days on routinely provided prophylactic antibiotics)
Time frame: 40 weeks
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)
Time frame: 40 weeks
Total number of days of hospitalizations due to infections
Total number of days of hospitalizations due to infections (rate per subject-year)
Time frame: 40 weeks
Geometric mean of IgG serum trough concentration
Geometric mean of IgG serum trough concentration at last study visit
Time frame: 40 weeks
Mean TSQM9
Treatment Satisfaction Questionnaire for Medication (TSQM9)
Time frame: 40 weeks
IRT-related adverse events
Nature and frequency of immune globulin-related adverse events
Time frame: 40 weeks
Hours of infusion clinic time required for IVIG administration
Hours of infusion clinic time required for IVIG administration
Time frame: 40 weeks
Mean total grams of immunoglobulin administered
Mean total grams of immunoglobulin administered per patient-year
Time frame: 40 weeks
Mean leukocyte counts at the last study visit
Mean leukocyte counts at the last study visit
Time frame: 40 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
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Common Variable Immunodeficiency →