Actively Recruiting
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
Led by University of Alberta · Updated on 2025-07-03
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe hypogammaglobulinemia defined as total IgG less than 4 g/L after subtracting IgG paraprotein fraction, if present
- Received CD19 targeted CAR T cell therapy within the past 6 months
- Consent to receive plasma-derived immunoglobulin products
- Ability to provide informed consent
You will not qualify if you...
- Inability to comply with study procedures
- Pregnancy or plans to conceive
- Breastfeeding
- Protein-losing conditions contributing to hypogammaglobulinemia (e.g., protein-losing enteropathy, nephrotic syndrome)
- Subcutaneous immune globulin infusion within the prior 3 months
- History of allergy or severe reactions to immune globulin products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Actively Recruiting
Research Team
K
Kathryn Rankin, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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