Using immunoglobulin to help patients with low antibody levels after CAR T cell therapy
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
This study is testing if giving immunoglobulin to patients with low antibody levels after CAR T cell therapy can help prevent infections and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | CAR T, Chimeric antigen receptor |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT06989541 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have severe HGG following CD19 targeted CAR T cell therapy within the last six months.
Not a fit: Patients who are pregnant, breastfeeding, or have certain protein-losing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of serious infections in patients with HGG after CAR T cell therapy.
How similar studies have performed: While the use of immunoglobulin replacement therapy is standard for managing HGG, this specific observational approach in the context of CAR T cell therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Kathryn Rankin, PhD
- Email: clinicaloutcomesresearch@albertahealthservices.ca
- Phone: 780-432-8771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.