Recruiting

CAR T Cells with IRT

Sponsor:

University of Alberta

Code:

NCT06989541

Conditions

Hypogammaglobulinemia, Acquired

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immune Globulin Intravenous (Human), 10%

Immune Globulin Subcutaneous (Human), 20% Solution

Study Details

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 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.

Conditions

Hypogammaglobulinemia, Acquired

Study ID

NCT06989541

Start date

Jun 1, 2025

Status verified date

Jul, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

IVIG

Intravenous Immunoglobulin Replacement

SCIG

Subcutaneous Immunoglobulin Replacement

Interventions

Immune Globulin Intravenous (Human), 10%

Intravenous immune globulin replacement

Immune Globulin Subcutaneous (Human), 20% Solution

Subcutaneous immune globulin replacement

Primary outcome measure

  • Time normalized rate of infections grade 3 or greater [ Time Frame: 40 weeks ]

Central Contacts and Locations

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jul 3, 2025

Last verified

Jul, 2025

Keywords

  • secondary immunodeficiency
  • CAR T
  • immune globulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-07-03.