Using immunoglobulin to help patients with low antibody levels after CAR T cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients who have developed hypogammaglobulinemia (HGG) following treatment with chimeric antigen receptor (CAR) T cell therapy. It aims to assess the frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in these patients receiving immunoglobulin replacement therapy (IRT), either intravenously (IVIG) or subcutaneously (SCIG). By monitoring these factors, the study seeks to understand the effectiveness of IRT in preventing infections and improving patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Kathryn Rankin, PhD
• Email: clinicaloutcomesresearch@albertahealthservices.ca
• Phone: 780-432-8771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.