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Can an immune booster stop serious infections in blood cancer patients?

NCT ID NCT07582432

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding Gamunex-C (an immune globulin) to standard care can prevent serious infections in people with chronic lymphocytic leukemia, multiple myeloma, or non-Hodgkin lymphoma. About 49 participants will receive Gamunex-C through an IV every 4 weeks for a year. The main goal is to see if the rate of serious bacterial infections drops.

What this could mean

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

Active substance
Gamunex-C (immune globulin injection)
What this could lead to
If it works, this could provide a way to reduce serious infections in people with blood cancers who have weakened immune systems.
What could go wrong
This is a small, single-arm trial with no placebo group, so results may be less reliable. Side effects from Gamunex-C can include headache, fever, and allergic reactions.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 49 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

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: Participants with documented and confirmed diagnosis of any of the diseases below: * B-cell CLL according to iwCLL criteria and Rai staging of intermediate (1 and 2) or high (3 and 4); or * MM according to the International Myeloma Working Group criteria (IMWG), R ISS stage II or, III; or * Histologically confirmed diagnosis of B-cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification. Participants with HGG with IgG levels \<5g/L at screening. Exclusion Criteria: * Participants with documented history of allogeneic hematopoietic stem cell transplant within 6 months before Screening Visit. * Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the Screening Visit. * Participants with any active infections at the time of Screening Visit. Participants with active secondary malignancies. * Participants with known PID. * Participants with a life expectancy less than 1.5 years. * Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk. * Participants who have had known serious treatment related adverse events to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product. * Participants who have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral PI which have decreased IgA in addition to decreased IgG requiring IgG replacement). * Females of childbearing potential who are pregnant, have a positive pregnancy test at Screening Visit (serum human chorionic gonadotropin-based assay), are breastfeeding, or unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence\*) throughout the study. Note: \*True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.) * Participants with severe known kidney disease (as defined by estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration \[eGFR CKD-EPI\] \<30 mL/min/1.73 m2) as determined by the Principal Investigator. * Participants that have liver enzyme levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase \[GGT\], or lactate dehydrogenase \[LDH\]) greater than 3 times the upper limit of normal at the Screening Visit as defined by the testing laboratory. * Participants who have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of thromboembolic events \[e.g., DVT, PE, ischemic stroke (transient ischemic attack, and any ischemic cerebrovascular accident), myocardial infarction (including unstable angina and ischemic heart disease diagnosed in the last 6 months), retinal artery occlusion, mesenteric ischemia, and peripheral arterial disease (Fontaine III and IV)\]\*.(Fontaine I: asymptomatic. IIa: mild claudication. IIb: moderate to severe claudication. III: ischemia with rest pain. IV: ulceration or gangrene). * Participants who currently have a known hyperviscosity syndrome or hypercoagulable states. * Participants who have clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection. * Participants with non-controlled arterial hypertension (i.e., SBP \> 160 mmHg and/or DBP \> 100 mmHg), and/or HR \>100 bpm. * Participants have known substance or prescription drug abuse within 12 months before the Screening Visit. * Participants have participated in another clinical trial within 30 days prior to Screening Visit (NOTE: observational studies without investigative treatments \[non-interventional\] and interventional studies to treat CLL, MM, or NHL are permitted). * Participants / caregivers are unwilling to comply with any aspect of the protocol for the duration of the study. * In the opinion of the investigator, participants may have compliance problems with the protocol and the procedures of the protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Study Site 101

    RECRUITING

    Fort Wayne, Indiana, 46894, United States

  • Study Site 102

    NOT_YET_RECRUITING

    St. Petersburg, Florida, 33709, United States

  • Study Site 103

    NOT_YET_RECRUITING

    Tacoma, Washington, 98405, United States

  • Study Site 104

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • Study Site 105

    NOT_YET_RECRUITING

    Westbrook, Maine, 04092, United States