Status:
RECRUITING
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
Lead Sponsor:
University of Alberta
Conditions:
Hypogammaglobulinemia, Acquired
Eligibility:
All Genders
18+ years
Brief Summary
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 call...
Detailed Description
Chimeric antigen receptor (CAR) T cells are patient-derived T cells engineered to express a fusion protein that directs them to target a tumor-associated antigen. The tumor-associated antigen CD19 is ...
Eligibility Criteria
Inclusion
- 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
- Ability to provide informed consent
Exclusion
- 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)
- SCIG infusion in the prior 3 months.
- History of allergy or severe reactions to immune globulin productions
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06989541
Start Date
June 1 2025
End Date
May 1 2027
Last Update
July 3 2025
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3