Hypogammaglobulinemia, AcquiredICARTNCT06989541
Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
An observational study of Hypogammaglobulinemia, Acquired, run by University of Alberta at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypogammaglobulinemia, Acquired
- What is being tested?
- Immune Globulin Intravenous (Human), 10% and Immune Globulin Subcutaneous (Human), 20% Solution
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with CD19 targeted CAR T cell therapy for B cell malignancy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G3
Adil Adatia, MD, 780-492-5381, adatia@ualberta.ca
About this study
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.
Read the 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 expressed on tumor cells in these conditions as well as on healthy cells of the B cell lineage. This results the "on-target off-tumor" effect of profound B cell depletion in these patients often with attendant hypogammaglobulinemia (HGG). Serious infections are common in this patient population and represent the main cause of non-relapse related mortality in CAR T cell treated patients.
Treatment of HGG with immunoglobulin replacement therapy (IRT) is a core component of infection prevention. Standard of care IRT can be administered intravenously (IVIG) or subcutaneously (SCIG). The proposed project will investigate frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in patients treated with CAR T-cell therapy who are treated with IVIG and SCIG.
- Conditions
- Hypogammaglobulinemia, Acquired
- Being tested
- Immune Globulin Intravenous (Human), 10%, Immune Globulin Subcutaneous (Human), 20% Solution
- Keywords
- secondary immunodeficiency, CAR T, immune globulin
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (Human), 10%Biological
Intravenous immune globulin replacement
Immune Globulin Subcutaneous (Human), 20% SolutionBiological
Subcutaneous immune globulin replacement
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Intravenous Immunoglobulin Replacement Receives: Biological: Immune Globulin Intravenous (Human), 10% | |
| SCIG | Subcutaneous Immunoglobulin Replacement Receives: Biological: Immune Globulin Subcutaneous (Human), 20% Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time normalized rate of infections grade 3 or greater
Time normalized rate of infections grade 3 or greater
Measured: 40 weeks
Secondary outcomes (10)
Time normalized rate of validated infections
Time normalized rate of infections (per subject-year) confirmed using microbiologic, clinical, and radiologic criteria
Measured: 40 weeks
Days on therapeutic antibiotics
Days on therapeutic antibiotics for treatment of an infection (excluding days on routinely provided prophylactic antibiotics)
Measured: 40 weeks
Days missed work/school/unable to perform normal daily activities due to infections
Days missed work/school/unable to perform normal daily activities due to infections (rate per subject-year)
Measured: 40 weeks
Total number of days of hospitalizations due to infections
Total number of days of hospitalizations due to infections (rate per subject-year)
Measured: 40 weeks
Geometric mean of IgG serum trough concentration
Geometric mean of IgG serum trough concentration at last study visit
Measured: 40 weeks
Mean TSQM9
Treatment Satisfaction Questionnaire for Medication (TSQM9)
Measured: 40 weeks
IRT-related adverse events
Nature and frequency of immune globulin-related adverse events
Measured: 40 weeks
Hours of infusion clinic time required for IVIG administration
Hours of infusion clinic time required for IVIG administration
Measured: 40 weeks
Mean total grams of immunoglobulin administered
Mean total grams of immunoglobulin administered per patient-year
Measured: 40 weeks
Mean leukocyte counts at the last study visit
Mean leukocyte counts at the last study visit
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogammaglobulinemia, AcquiredStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989541
- Sponsor's protocol ID
- HREBA.CC-24-0422
- Acronym
- ICART
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin for Hypogammaglobulinemia Due to Chimeric Antigen Receptor T Cell Therapy
- ClinicalTrials.gov ID
- NCT06989541
- Acronym / sponsor ID
- ICART / HREBA.CC-24-0422
- Conditions
- Hypogammaglobulinemia, Acquired
- Keywords
- secondary immunodeficiency, CAR T, immune globulin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 expressed on tumor cells in these conditions as well as on healthy cells of the B cell lineage. This results the "on-target off-tumor" effect of profound B cell depletion in these patients often with attendant hypogammaglobulinemia (HGG). Serious infections are common in this patient population and represent the main cause of non-relapse related mortality in CAR T cell treated patients.
Treatment of HGG with immunoglobulin replacement therapy (IRT) is a core component of infection prevention. Standard of care IRT can be administered intravenously (IVIG) or subcutaneously (SCIG). The proposed project will investigate frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in patients treated with CAR T-cell therapy who are treated with IVIG and SCIG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIG | – | Biological: Immune Globulin Intravenous (Human), 10%Intravenous Immunoglobulin Replacement |
| SCIG | – | Biological: Immune Globulin Subcutaneous (Human), 20% SolutionSubcutaneous Immunoglobulin Replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with CD19 targeted CAR T cell therapy for B cell malignancy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Globulin Intravenous (Human), 10%Intravenous immune globulin replacement | Biological | IVIG |
| Immune Globulin Subcutaneous (Human), 20% SolutionSubcutaneous immune globulin replacement | Biological | SCIG |
Primary outcome
Time normalized rate of infections grade 3 or greater
Time frame: 40 weeks
Time normalized rate of infections grade 3 or greater
10 secondary outcomes
Time normalized rate of validated infections
Time frame: 40 weeks
Days on therapeutic antibiotics
Time frame: 40 weeks
Days missed work/school/unable to perform normal daily activities due to infections
Time frame: 40 weeks
Total number of days of hospitalizations due to infections
Time frame: 40 weeks
Geometric mean of IgG serum trough concentration
Time frame: 40 weeks
Mean TSQM9
Time frame: 40 weeks
IRT-related adverse events
Time frame: 40 weeks
Hours of infusion clinic time required for IVIG administration
Time frame: 40 weeks
Mean total grams of immunoglobulin administered
Time frame: 40 weeks
Mean leukocyte counts at the last study visit
Time frame: 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogammaglobulinemia, Acquired, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Rankin, PhD (780-432-8771, clinicaloutcomesresearch@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time normalized rate of infections grade 3 or greater (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.