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Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

Recruitingn/aAges 18 Years - anyAllUniversity of Alberta
NCT06989541 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years 2. Severe HGG defined as total IgG \<4 g/L (after subtracting the IgG paraprotein fraction, if present) 3. Treated with CD19 targeted CAR T cell therapy in the past 6 months 4. Consent to receive plasma-derived productions 5. Ability to provide informed consent Exclusion Criteria: 1. Inability to comply with study procedures 2. Pregnancy or planning to conceive 3. Breastfeeding 4. Protein-losing conditions that may contribute to HGG (e.g., protein-losing enteropathy, nephrotic syndrome) 5. SCIG infusion in the prior 3 months. 6. History of allergy or severe reactions to immune globulin productions
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What it tests

  • Immune Globulin Intravenous (Human), 10%
  • Immune Globulin Subcutaneous (Human), 20% Solution
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Where

1 site
University of Alberta
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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