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Study of Human Normal Immunoglobulin in Adults with Secondary Immune Deficiency after CAR T‑cell or T‑cell Redirecting Therapy for Hematologic Malignancies

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What is this trial about?

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

The study focuses on adults who have Secondary Immune Deficiency, a condition where the body’s ability to fight infections is weakened because of another illness, most often a type of blood cancer called hematologic malignancies. Many of these patients have previously received advanced cancer treatments that use engineered immune cells, such as chimeric antigen receptor T‑cell therapy or other T‑cell redirecting therapies. The medication being tested is a medicine known as IgPro20, which contains normal human antibodies and is given as a liquid that is injected just under the skin (subcutaneous injection).

The main goal of the research is to determine whether the yearly number of serious bacterial infections in participants receiving IgPro20 is less than one. Participants will receive the medication on a regular schedule and will have periodic check‑ups where doctors look for signs of infection, record any hospital stays, and take blood samples to measure antibody levels. Researchers will also track any side effects that occur during the study.

Throughout the trial, each person will be followed for several months while continuing their usual care. Visits will include simple physical examinations, questionnaires about health, and laboratory tests that help assess how the medication works in the body and whether it is safe. All collected information will be used to understand the frequency of infections, the need for additional treatments, and overall safety of the therapy.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment Confirmation

    You have been confirmed as a participant in the study after meeting the eligibility criteria for secondary immune deficiency.

    All required consent forms have been signed and you have received the study information.

  2. Step 2

    Baseline Assessments

    A series of medical evaluations are performed, including a review of your medical history, physical examination, and blood tests to measure your current immunoglobulin G (IgG) levels.

    These assessments establish a reference point before you start the study medication.

  3. Step 3

    First Administration of <b>Hizentra</b>

    You receive the first dose of Hizentra, a human normal immunoglobulin solution for subcutaneous injection.

    The dose is calculated based on your body weight in milligrams per kilogram (mg/kg) and is delivered under the skin (subcutaneous use).

    The exact amount and schedule are determined by the study protocol and your physician.

  4. Step 4

    Regular Subcutaneous Injections

    You continue to receive Hizentra by subcutaneous injection on a regular schedule, typically once a week, for the duration of the study.

    Each injection is prepared according to the dose calculated from your weight and administered either at the clinic or at home as instructed.

  5. Step 5

    Scheduled Clinic Visits

    You attend regular clinic visits, usually every four weeks, where health professionals check your overall condition, record any infections, and collect blood samples.

    The blood samples are used to measure trough IgG concentrations, peak levels (Cmax), and other pharmacokinetic parameters such as the area under the concentration‑time curve (AUC).

  6. Step 6

    Infection Monitoring

    You are asked to monitor and record any signs of infection, such as fever, cough, or pain, and to report them promptly to the study team.

    The study tracks serious bacterial infections (SBIs)—including bloodstream infection, bacterial meningitis, bone or joint infection, bacterial pneumonia, and visceral abscess—as well as all other infections.

  7. Step 7

    Adverse Event Reporting

    Any side effects, including reactions at the injection site, flu‑like symptoms, or more serious events, are documented during each visit or reported by you at any time.

    Events are classified according to severity, with particular attention to grade 3 or higher infections and any serious adverse events.

  8. Step 8

    End‑of‑Study Evaluation

    At the conclusion of the study period, a final set of assessments is performed, including a comprehensive review of infection rates, hospitalizations, and overall safety.

    Blood samples are taken to evaluate the final IgG levels and pharmacokinetic measurements.

    The study results will determine whether the annualized rate of serious bacterial infections is less than one per participant.

Who can join the trial?

9 criteria

  • Be at least 18 years old when you sign the written consent form.
  • Have a confirmed diagnosis of a B‑cell blood cancer such as multiple myeloma, chronic lymphocytic leukemia, non‑Hodgkin lymphoma, or B‑cell acute lymphoblastic leukemia. (B‑cell hematologic malignancy means a type of cancer that starts in the blood‑forming cells called B‑cells.)
  • Have been treated with either CAR T‑cell therapy (a treatment that re‑programs your own immune cells to attack cancer) or a TCE BsAb (a special antibody that links two targets to help the immune system fight cancer) and meet one of the following timing rules:
    • At least 2 months have passed since you received an approved CAR T‑cell therapy, or
    • At least 1 month has passed since you started an approved TCE BsAb therapy and you plan to keep taking it.
    • Show a partial or complete response to the CAR T‑cell or TCE BsAb therapy, meaning your doctor has determined that the cancer is shrinking or gone based on standard response guidelines for your specific disease.
    • If you are currently receiving immunoglobulin replacement therapy (either IVIG – intravenous immunoglobulin, or SCIG – subcutaneous immunoglobulin) for secondary immune deficiency, any level of IgG (a type of antibody) at screening is allowed. You will be placed in:
      • The Loading Cohort if your IgG level is less than 500 mg/dL, or
      • The Maintenance‑only Cohort if your IgG level is 500 mg/dL or higher.
      • If you are not receiving immunoglobulin replacement therapy (no IVIG for more than 8 weeks and no SCIG for more than 2 weeks) and are not expected to start it during screening, you must have an IgG level less than 500 mg/dL to join (you will be assigned to the Loading Cohort).
      • Both men and women are eligible to participate.

Who cannot join the trial?

7 criteria

  • You cannot join if you have a known history of any disease that usually requires IgRT (immunoglobulin replacement therapy), such as primary immune deficiency (a condition where the immune system is weak from the start), chronic inflammatory demyelinating polyneuropathy (a nerve disorder that causes weakness), Guillain‑Barré syndrome (a rapid‑onset nerve problem), immune thrombocytopenia (low blood platelets that affect clotting), Kawasaki disease (a childhood illness that inflames blood vessels), Lambert‑Eaton myasthenic syndrome (a muscle‑weakness disorder), multifocal motor neuropathy (a nerve disease causing muscle weakness), myasthenia gravis (a condition that makes muscles tire quickly), stiff person syndrome (a rare disorder causing muscle stiffness), a solid organ transplant (receiving an organ such as a kidney or liver), or organ rejection before screening.
  • You cannot join if you have had a thromboembolic event (TEE) (a blood clot that traveled to another part of the body, such as the lungs) within the six months before the screening visit.
  • You cannot join if your overall health and ability to perform daily activities is rated higher than 1 on the Eastern Cooperative Oncology Group performance status scale, which means you are not fully able to carry out normal activities.
  • You cannot join if you have any active infection that is affecting your whole body (a systemic active infection) at the time of screening.
  • You cannot join if you are taking any medicines that are not allowed in this study, including antibiotics or other anti‑infective treatments (drugs that fight infections).
  • You cannot join if a blood test shows a very low number of neutrophils (a type of white blood cell that fights infection) below 1 × 10⁹/L, which is classified as CTCAE Grade 3 (a serious level), unless a doctor can prove the low count is caused by your underlying disease and can be raised with a medication called granulocyte colony‑stimulating factor.
  • You cannot join if you are already participating in another experimental treatment study (interventional clinical study) at the same time, unless the other study does not affect your safety or the results of this study.
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Investigated drugs

Hizentra is a liquid medicine that you inject under the skin. It contains normal human immune proteins called immunoglobulins. These proteins help protect the body against infections. In this study, Hizentra is given to people whose immune systems are weak because of blood cancers and the special cancer treatments they received. The goal is to see if Hizentra can lower the number of serious bacterial infections they get.

B‑cell targeting chimeric antigen receptor (CAR) T‑cell therapy is a type of treatment where a patient’s own T cells (a kind of white blood cell) are taken out, genetically changed in the lab to recognize and attack B‑cells that have become cancerous, and then put back into the patient. This therapy is used to treat certain blood cancers and can also affect the normal immune system, making patients more prone to infections.

T‑cell redirecting therapies are medicines that act like a bridge, connecting a patient’s T cells to cancer cells. They are often made of two parts: one part grabs onto the T cell, and the other part grabs onto a marker on the cancer cell. By linking the two, they help the immune system find and kill the cancer. Like CAR T‑cell therapy, these treatments can also lower the body’s ability to fight everyday infections.

What is already known about the treatment

Hizentra - Hizentra is given as a liquid that is injected under the skin, allowing the medicine to be absorbed slowly. It is an already approved human normal immunoglobulin used to replace missing antibodies in people with immune deficiency. It is mainly used to prevent infections in patients whose immune system is weak, such as those with secondary immune deficiency after cancer treatments. The drug works by providing a broad range of antibodies that bind to germs and help the body fight them, and it belongs to the class of normal human immunoglobulins for extravascular administration.

Investigated diseases

Secondary Immune Deficiency - Secondary immune deficiency is a condition in which the body's ability to fight infections is reduced because of another disease, medication, or medical treatment. It occurs when factors such as chemotherapy, organ transplantation, or certain infections damage or suppress the immune system. As the immune response weakens, the person becomes more prone to bacterial, viral, and fungal infections. Over time, if the underlying cause remains, the frequency and severity of infections can increase. The condition may fluctuate, improving if the trigger is removed or worsening if exposure continues.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525626-38-00Protocol codeIgPro20_3013Estimated enrolment31 patientsSponsorCSL Behring LLC

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