RecruitingNCT06989541

Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy


Sponsor

University of Alberta

Enrollment

30 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study examines how well immunoglobulin replacement therapy (IRT) — antibody infusions given either intravenously (IVIG) or under the skin (SCIG) — prevents bacterial infections in patients who have received CD19-targeted CAR T-cell therapy for blood cancers and have developed low antibody levels (hypogammaglobulinemia) as a side effect. CAR T-cell therapy destroys healthy B cells along with cancer cells, leaving patients vulnerable to serious infections. Adults aged 18 and older who received CD19-targeted CAR T-cell therapy in the past 6 months and have severely low IgG levels (below 4 g/L) are eligible. Participation involves receiving standard IRT as clinically indicated while researchers track infection rates, side effects, quality of life, and treatment satisfaction over time. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALImmune Globulin Intravenous (Human), 10%

Intravenous immune globulin replacement

BIOLOGICALImmune Globulin Subcutaneous (Human), 20% Solution

Subcutaneous immune globulin replacement


Locations(1)

University of Alberta

Edmonton, Alberta, Canada

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NCT06989541


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