NCT06989541

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2025May 2027

First Submitted

Initial submission to the registry

May 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

May 16, 2025

Last Update Submit

July 2, 2025

Conditions

Hypogammaglobulinemia, Acquired

Keywords

secondary immunodeficiencyCAR Timmune globulin

Outcome Measures

Primary Outcomes (1)

  • Time normalized rate of infections grade 3 or greater

    Time normalized rate of infections grade 3 or greater

    40 weeks

Secondary Outcomes (10)

  • Time normalized rate of validated infections

    40 weeks

  • Days on therapeutic antibiotics

    40 weeks

  • Days missed work/school/unable to perform normal daily activities due to infections

    40 weeks

  • Total number of days of hospitalizations due to infections

    40 weeks

  • Geometric mean of IgG serum trough concentration

    40 weeks

  • +5 more secondary outcomes

Study Arms (2)

IVIG

Intravenous Immunoglobulin Replacement

Biological: Immune Globulin Intravenous (Human), 10%

SCIG

Subcutaneous Immunoglobulin Replacement

Biological: Immune Globulin Subcutaneous (Human), 20% Solution

Interventions

Immune Globulin Intravenous (Human), 10%BIOLOGICAL

Intravenous immune globulin replacement

IVIG
Immune Globulin Subcutaneous (Human), 20% SolutionBIOLOGICAL

Subcutaneous immune globulin replacement

SCIG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with CD19 targeted CAR T cell therapy for B cell malignancy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

gamma-GlobulinsSolutions

Condition Hierarchy (Ancestors)

Immunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPharmaceutical Preparations

Central Study Contacts

Kathryn Rankin, PhD

CONTACT

780-432-8771clinicaloutcomesresearch@albertahealthservices.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 25, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)