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IgPro20 for Secondary Immune Deficiencies in Blood Cancers

This study is testing IgPro20, a biological medicine, in adults who have blood cancers like multiple myeloma or lymphoma. These patients have also received certain B-cell targeting therapies (like CAR T-cell or T-cell redirecting therapies) which can weaken their immune system, leading to secondary immune deficiency. The study wants to see if IgPro20 can help reduce serious bacterial infections. Researchers will also look at how safe IgPro20 is and how it moves through the body. The main goal is to show that the yearly rate of serious bacterial infections is less than 1.0. You might be able to join if you are 18 or older, have a confirmed blood cancer, and have received these specific B-cell therapies.

Study design
This is an open-label, single-arm study, meaning all participants will receive IgPro20 and everyone involved will know what treatment is being given. The study plans to enroll 63 participants across multiple locations.
What's involved
Participants will receive IgPro20 infusions under the skin. If your IgG (a type of antibody) is low at the start, you will receive five doses of IgPro20 during an initial treatment period.
Compensation
Not stated in the trial record.
Follow-up
The study will measure serious bacterial infections for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07648264

Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
CSL Behring
~63 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:IgPro20

At a glance

Recruiting sites
0 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Serious Bacterial Infections (SBIs) per Participant
Measured over Up to Month 12

Conditions

Secondary Immune Deficiency

Explore related trials

B Acute Lymphoblastic LeukemiaChronic Lymphocytic LeukemiaHematologic NeoplasmMultiple MyelomaNon-Hodgkin LymphomaSecondary immune deficiency disorder

Where it's being run

60 sites across 48 states
Italy4
Florida2
Maryland2
New Jersey2
New York2
Belgium2
Czechia2
Denmark2

Who to contact

Trial Registration Coordinator
[email protected]
+16108784697
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants greater than or equal to (≥) 18 years of age at the time of providing written informed consent.
Confirmed diagnosis of B-cell hematologic malignancy (ie, Multiple myeloma \[MM\], Chronic lymphocytic leukemia \[CLL\], Non-Hodgkin lymphoma \[NHL\], or BALL) according to applicable diagnostic criteria.
Participants treated with Chimeric antigen receptor T-cell (CAR T-cell) therapy or TCE BsAb and are:
Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening:
IgG level (excluding paraprotein, if relevant) at Screening:
IgG level (excluding paraprotein, if relevant) at Screening:

Exclusion

Documented history of diseases for which IgRT may be indicated: primary immune deficiency, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, immune thrombocytopenia, Kawasaki disease, Lambert-Eaton myasthenic syndrome, multifocal motor neuropathy, myasthenia gravis, stiff person syndrome, solid organ transplant, and rejection prior to Screening.
History of thromboembolic event (TEE) within 6 months before Screening.
Eastern Cooperative Oncology Group performance status \> 1.
Presence of any systemic active infection at Screening.
Participants on any prohibited therapies, including anti-infective treatments.
Absolute neutrophil count \< 1 × 10\*9/L (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or worse), unless proven to be due to the underlying disease and raised above the limit by granulocyte colony-stimulating factor.
Concurrent participation in other interventional clinical studies. Note: a participant may be enrolled if their participation in the other study will not jeopardize their safety and / or the scientific validity of this study (eg, an observational study, a long-term safety follow-up of an interventional study, diagnostic device studies, phase 4 studies with medicines used within their approved indication); the investigator may consult with the medical monitor.

What this trial measures

  • Number of Serious Bacterial Infections (SBIs) per ParticipantUp to Month 12

    The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.