Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Inability to comply with study procedures

Pregnancy or planning to conceive

Breastfeeding

Protein-losing conditions that may contribute to HGG (e.g., protein-losing enteropathy, nephrotic syndrome)

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators