Actively Recruiting

Age: 18Years +
All Genders
NCT06989541

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G 2G3

Actively Recruiting

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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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