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RECRUITING
NCT06989541

Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-06-01

Completion Date

2027-05-01

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Immune Globulin Intravenous (Human), 10%

Intravenous immune globulin replacement

BIOLOGICAL

Immune Globulin Subcutaneous (Human), 20% Solution

Subcutaneous immune globulin replacement

Locations (1)

University of Alberta

Edmonton, Alberta, Canada