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Clinical Trial of Human Normal Immunoglobulin to Prevent Infections in Patients with Secondary Antibody Deficiency due to CLL, Multiple Myeloma or Non‑Hodgkin Lymphoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial looks at people who have blood cancers such as Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. These illnesses can cause Secondary Antibody Deficiency, meaning the body's ability to make antibodies is reduced, a condition also called hypogammaglobulinemia. Low antibodies make infections more likely. The study will give participants a medicine called Gamunex-C, which is a preparation of human normal immunoglobulin, administered by intravenous infusion every four weeks together with their usual medical care.

The purpose is to see whether this approach can keep the number of serious bacterial infections low over a one‑year period. Participants will receive the infusion regularly for twelve months, attend routine visits to monitor health and any infections, and will continue any standard therapies they already use. The study will track how often infections occur, how long they last, any hospital stays, and will also watch for side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, you will complete a consent form and provide information about your health history, current medications, and any recent infections.

    The study team will perform blood tests and other examinations to establish a baseline before any treatment begins.

  2. Step 2

    First <b>gamunex®-c</b> infusion

    You will receive an intravenous infusion of gamunex®-c, which is a solution containing human normal immunoglobulin.

    The dose is calculated as 600 mg per kilogram of your body weight and is delivered through a vein over a period determined by the clinical staff.

    This infusion marks the start of the medication schedule that will continue for one year.

  3. Step 3

    Monthly infusions (every 4 weeks)

    Approximately every four weeks, you will return for another intravenous infusion of gamunex®-c at the same dose of 600 mg/kg.

    The schedule continues for a total period of twelve months, so you will receive about twelve infusions in total.

  4. Step 4

    Continuation of standard medical treatment

    Throughout the trial you will keep taking any regular medicines prescribed for your underlying condition, such as treatments for chronic lymphocytic leukaemia, multiple myeloma, or non‑hodgkin lymphoma.

    The study does not change these therapies; they are continued as usual.

  5. Step 5

    Regular monitoring visits and safety checks

    Before each infusion, you will have a brief visit where blood samples are taken to check your immune status and kidney function.

    The staff will ask about any new infections, side effects, or other health changes since the previous visit.

    If a serious bacterial infection (an infection that requires hospitalization or intravenous antibiotics) occurs, it will be recorded as part of the study outcomes.

  6. Step 6

    Final assessment after the last infusion

    At the end of the twelve‑month treatment period, you will undergo a final set of examinations, including blood tests and a review of any infections that occurred during the study.

    The results will be used to evaluate the overall safety and effectiveness of the treatment.

  7. Step 7

    Study completion

    After the final assessment, your participation in the trial ends.

    You will receive a summary of the study findings and any recommendations for continued care from your regular healthcare provider.

Who can join the trial?

4 criteria

  • Be at least 18 years old at the time of the screening visit.
  • Have a confirmed diagnosis of one of the following blood cancers: B‑cell Chronic Lymphocytic Leukemia (CLL) that meets standard laboratory criteria and is in an intermediate (stage 1‑2) or high (stage 3‑4) risk level; Multiple Myeloma (MM) that meets international criteria and is classified as stage II or III; or B‑cell Non‑Hodgkin Lymphoma (NHL) that is stage III or higher (including stage IV, progressive, refractory, or relapsed disease). (These terms describe different types of cancers that affect white blood cells, and “stage” indicates how advanced the disease is.)
  • Show low IgG levels (a type of antibody that helps fight infection) measured at less than 5 g/L during screening, a condition known as hypogammaglobulinemia (HGG).
  • Sign the informed consent form (ICF) before any study‑related procedures begin.

Who cannot join the trial?

19 criteria

  • Had a donor stem cell transplant (a transplant from another person) within the last 6 months before the screening visit.
  • Has severe kidney disease, shown by an estimated glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m², which means the kidneys are not filtering well.
  • Has liver enzyme levels (including ALT, AST, GGT, or LDH) that are more than three times higher than the normal range, indicating possible liver problems.
  • Has a history of blood‑clot problems (such as deep‑vein clot, lung clot, stroke, heart attack, or other clot‑related events) – either one episode in the past year or two episodes at any time.
  • Currently has a condition that makes the blood too thick (hyperviscosity syndrome) or a tendency for the blood to clot too easily (hypercoagulable state).
  • Shows signs of an active hepatitis B or hepatitis C infection (viral infections of the liver).
  • Has uncontrolled high blood pressure (systolic over 160 mm Hg or diastolic over 100 mm Hg) or a fast heart rate (over 100 beats per minute).
  • Has used illegal drugs or misused prescription drugs within the past 12 months.
  • Has taken part in another clinical trial within the past 30 days (except for non‑interventional observational studies).
  • Is unwilling or unable to follow any part of the study procedures for the whole study period.
  • The investigator believes the participant may have trouble following the study rules or procedures.
  • Is currently receiving, or has received within the last 6 months, immunoglobulin replacement therapy (IgG therapy) to boost the immune system.
  • Has any active infection at the time of screening, or has an active second cancer (a new cancer different from the main disease).
  • Has a known primary immunodeficiency disease (a genetic disorder that weakens the immune system).
  • Has a life expectancy of less than 1.5 years.
  • Has any other serious acute or chronic illness that, in the investigator’s opinion, could interfere with completing the study safely.
  • Has had a serious allergic reaction (anaphylaxis) to immunoglobulin products or any blood‑derived product.
  • Has selective Immunoglobulin A (IgA) deficiency, meaning very low levels of IgA antibodies, with or without antibodies against IgA.
  • Is a woman who could become pregnant and is currently pregnant, has a positive pregnancy test, is breastfeeding, or is not using a highly effective form of birth control (such as hormonal methods, intrauterine device, condoms with spermicide, permanent sterilization, or true abstinence).
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Investigated drugs

  • Gamunex-C

    is a medication made from normal human antibodies. It is given through an IV (intravenous infusion) every four weeks. In this trial, it is used to raise the level of antibodies in people whose immune systems are weak because of blood cancers, helping them fight off serious bacterial infections.

  • Standard Medical Treatment

    refers to the usual care that patients with chronic lymphocytic leukemia, multiple myeloma, or non‑Hodgkin lymphoma receive. This includes the regular chemotherapy, targeted therapies, and supportive medicines that doctors normally give to treat the cancer and manage symptoms. In the study, it is continued alongside Gamunex‑C to see how the combination works to prevent infections.

What is already known about the treatment

Gamunex® 10%, 100 mg/ml, solution for infusion - This medication is given as an intravenous infusion, usually once every four weeks, where the liquid is slowly delivered into a vein. It is an approved human normal immunoglobulin product that is widely used and described in medical literature for replacing missing antibodies. It is mainly used to help prevent serious infections in people whose blood cancers (such as chronic lymphocytic leukemia, multiple myeloma, or non‑Hodgkin lymphoma) have caused low levels of natural antibodies. The drug works by supplying a broad mix of normal antibodies that can recognize and neutralize many germs, supporting the body’s own immune defenses, and it belongs to the pharmacological class of immune globulins (normal human immunoglobulin).

Investigated diseases

  • Chronic Lymphocytic Leukemia

    A slow‑growing cancer of B‑cell lymphocytes that builds up in the blood, bone marrow, and lymph nodes. Over time the number of abnormal cells increases and can crowd out normal blood cells, leading to reduced immune function.

  • Multiple Myeloma

    A cancer of plasma cells that reside in the bone marrow. The malignant cells produce excess protein and displace normal blood cells, causing bone damage and a decline in the body’s antibody production.

  • Non‑Hodgkin Lymphoma

    A diverse group of cancers that arise from lymphocytes and can form tumors in lymph nodes or other organs. As the disease spreads, it gradually impairs the normal immune system.

  • Secondary Antibody Deficiency associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non‑Hodgkin Lymphoma

    A condition in which the cancers listed above lower the level of immunoglobulins, weakening the body’s ability to make antibodies. This reduction in antibody levels makes patients increasingly susceptible to infections as the underlying disease progresses.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526803-31-00Protocol codeGC2502Estimated enrolment49 patientsSponsorGrifols Therapeutics LLC

sourced from the EU Clinical Trials Register and site verification

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