Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Severe HGG defined as total IgG \<4 g/L (after subtracting the IgG paraprotein fraction, if present)

• Treated with CD19 targeted CAR T cell therapy in the past 6 months

• Consent to receive plasma-derived productions

• Ability to provide informed consent

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
Contact Information
Primary
Kathryn Rankin, PhD
clinicaloutcomesresearch@albertahealthservices.ca
780-432-8771
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 30
Treatments
IVIG
Intravenous Immunoglobulin Replacement
SCIG
Subcutaneous Immunoglobulin Replacement
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov

Similar Clinical Trials