Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy

Plain-language summary

Chimeric antigen receptor (CAR) T cells target the CD19 marker on cancer cells but can also destroy healthy B cells, which may cause hypogammaglobulinemia (HGG) and leave patients less able to fight infections. This study examines immunoglobulin replacement therapy given intravenously (IVIG) or subcutaneously (SCIG) in patients who develop HGG after CAR T cell therapy. Eligible participants are 18 or older, treated with CD19-targeted CAR T cell therapy within the past 6 months, with severe HGG defined as total IgG below 4 g/L, and consent to receive plasma-derived products.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

University of Alberta

Intervention

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

Start date

6/1/2025

Estimated completion

5/1/2027

Countries

Canada

Related genes

Locations

• Edmonton, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Age ≥18 years
2. Severe HGG defined as total IgG \<4 g/L (after subtracting the IgG paraprotein fraction, if present)
3. Treated with CD19 targeted CAR T cell therapy in the past 6 months
4. Consent to receive plasma-derived productions
5. Ability to provide informed consent

Exclusion Criteria:

1. Inability to comply with study procedures
2. Pregnancy or planning to conceive
3. Breastfeeding
4. Protein-losing conditions that may contribute to HGG (e.g., protein-losing enteropathy, nephrotic syndrome)
5. SCIG infusion in the prior 3 months.
6. History of allergy or severe reactions to immune globulin productions