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Can replacement antibodies shield CAR t patients from infection?

NCT ID NCT06989541

Prevention Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

CAR T-cell therapy attacks cancer cells but can also wipe out healthy B cells, leaving patients with low antibody levels and a higher risk of serious infections. This trial studies immunoglobulin replacement therapy, given either through a vein or under the skin, in adults who have low antibody levels within six months of CD19-targeted CAR T-cell treatment. Researchers track serious infections, antibiotic use, quality of life, and side effects to see how the two delivery methods compare.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
immunoglobulin replacement therapy given through a vein or under the skin
What this could lead to
If it works, this could clarify the best way to give immunoglobulin replacement and lower the risk of serious infections after CAR T-cell therapy.
What could go wrong
This is a small study of 30 people, so it may not show clear differences between the two delivery methods. Immunoglobulin can cause infusion reactions, and it does not restore the immune system's own antibody production.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

common variable immunodeficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypogammaglobulinemia, acquired

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

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