Can an immune booster stop serious infections in blood cancer patients?
NCT ID NCT07582432
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Study Site 101
RECRUITINGFort Wayne, Indiana, 46894, United States
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Study Site 102
NOT_YET_RECRUITINGSt. Petersburg, Florida, 33709, United States
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Study Site 103
NOT_YET_RECRUITINGTacoma, Washington, 98405, United States
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Study Site 104
NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
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Study Site 105
NOT_YET_RECRUITINGWestbrook, Maine, 04092, United States