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New hope for cancer survivors: drug aims to shield against Life-Threatening infections

NCT ID NCT07648264

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests a drug called IgPro20 in 63 adults who have a weakened immune system after receiving CAR T-cell therapy for blood cancers like lymphoma or multiple myeloma. The goal is to see if the drug can lower the number of serious bacterial infections, such as pneumonia or sepsis. Participants will receive regular doses of IgPro20 and be monitored for infections and side effects over time.

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 63 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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 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: 1. At least 2 months after receipt of an approved CAR T-cell therapy for the B-cell hematologic malignancy at the time of Screening, or 2. At least 1 month after initiation of an approved TCE BsAb therapy for the B-cell hematologic malignancy at the time of Screening and expected to continue with the therapy. * Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening: 1. CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria 2. MM based on International Myeloma Working Group response criteria 3. NHL based on Lugano Classification criteria 4. B-ALL based on National Comprehensive Cancer Network guidelines * IgG level (excluding paraprotein, if relevant) at Screening: If participant has ongoing IgRT (intravenous immunoglobulin \[IVIG\] or subcutaneous immunoglobulin \[SCIG\]) for SID during Screening, then any IgG level at Screening is acceptable for enrollment. Participants with IgG less than (\<) 500 milligrams per deciliter (mg/dL) are assigned to the Loading Cohort, participants with IgG ≥ 500 mg/dL are assigned to the Maintenance-only Cohort. * IgG level (excluding paraprotein, if relevant) at Screening: If participant does not have ongoing IgRT (IVIG for \> 8 weeks or SCIG for \> 2 weeks) for SID during Screening and are not expected to receive IgRT during Screening, then IgG \< 500 mg/dL is required for enrollment (participant is assigned to the Loading Cohort) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

agammaglobulinemia B-cell acute lymphoblastic leukemia B-cell chronic lymphocytic leukemia Burkitt lymphoma hematopoietic and lymphoid system neoplasm non-Hodgkin lymphoma plasma cell myeloma

As listed by the trial registrant

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

Secondary immune deficiency

How to take part

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

  1. The places running it

    59 sites in 11 countries. 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

  • AZ Delta

    NOT_YET_RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Aidport sp z o.o.

    NOT_YET_RECRUITING

    Skorzewo (Poznan), Wielkopolska, 60185, Poland

  • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Azienda Ospedaliera Universitaria Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)

    NOT_YET_RECRUITING

    Catania, 95124, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari)

    NOT_YET_RECRUITING

    Brescia, Lombardy, 25123, Italy

  • CBCI, Colorado Blood Cancer Institute

    NOT_YET_RECRUITING

    Denver, Colorado, 80218, United States

  • CHU Angers - Hôpital Hôtel Dieu

    NOT_YET_RECRUITING

    Angers, Maine Et Loire, 49933 Angers Cedex 09, France

  • CHU Rennes - Hopital Pontchaillou

    NOT_YET_RECRUITING

    Rennes, ILE ET Vilaine, 35033, France

  • CHU de Liège

    NOT_YET_RECRUITING

    Liège, 4000, Belgium

  • CHU de Nantes-Hotel Dieu

    NOT_YET_RECRUITING

    Nantes, Loire Atlantique, 44093, France

  • Carol G Simon Cancer Center

    NOT_YET_RECRUITING

    Morristown, New Jersey, 07960, United States

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, 76038, France

  • Centre Hospitalier Départemental Les Oudairies

    NOT_YET_RECRUITING

    La Roche-sur-Yon, Vendée, 85925, France

  • David H. Koch Center for Cancer Care

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Department of Medicine, Vejle Hospital

    NOT_YET_RECRUITING

    Vejle, South Region Denmark, 7100, Denmark

  • Duke University

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • FH Hradec Kralove

    NOT_YET_RECRUITING

    Hradec Králové, Hradec Králové Region, 50005, Czechia

  • FH Ostrova

    NOT_YET_RECRUITING

    Ostrova, CZE, 70852, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    NOT_YET_RECRUITING

    Prague, 10034, Czechia

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    NOT_YET_RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario A. gemelli, IRCCS

    NOT_YET_RECRUITING

    Rome, Lazio, 00168, Italy

  • Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

    NOT_YET_RECRUITING

    Candiolo, Torino, 10060, Italy

  • Fred Hutchinson Cancer Research Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Hackensack Meridian Health

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hammersmith Hospital

    NOT_YET_RECRUITING

    London, Greater London, W12 0HS, United Kingdom

  • Horizon Health Network

    NOT_YET_RECRUITING

    Fredericton, New Brunswick, E3B 5N5, Canada

  • Hospital Clinic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, Barcelona/Catalonia, 08034, Spain

  • Hospital Universitari Germans Trias i Pujol

    NOT_YET_RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Marques de Valdecilla

    NOT_YET_RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario del Vinalopó

    NOT_YET_RECRUITING

    Elche, Alicante, 3560, Spain

  • Indiana University Health Arnett, Inc.

    NOT_YET_RECRUITING

    Lafayette, Indiana, 47904, United States

  • Johns Hopkins Asthma & Allergy Center

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21224, United States

  • Leicester Royal Infirmary

    NOT_YET_RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • MICS Centrum Medyczne Torun

    NOT_YET_RECRUITING

    Torun, Kuyavian-Pomeranian Voivodeship, 87100, Poland

  • Mayo Clinic - Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • McGill University Health Research Institute

    NOT_YET_RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Montefiore Medical Center PRIME

    NOT_YET_RECRUITING

    The Bronx, New York, 10467, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

    NOT_YET_RECRUITING

    Gliwice, Sielesia, 44102, Poland

  • Ospedale San Raffaele

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Ospedale di Circolo Fondazione Macchi

    NOT_YET_RECRUITING

    Varese, Lombardy, 21100, Italy

  • Penn State Hershey Medical Center

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Pratia ES HLA Hospital Universitario Moncloa

    NOT_YET_RECRUITING

    Madrid, 28008, Spain

  • Pratia MCM Krakow

    NOT_YET_RECRUITING

    Krakow, Małopolska, 30224, Poland

  • Pratia Onkologia Katowice

    NOT_YET_RECRUITING

    Katowice, Silesian Voivodeship, 40519, Poland

  • Rigshospitalet

    TERMINATED

    Copenhagen, 2100, Denmark

  • SSAK Partners

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • St Bartholomew's Hospital

    NOT_YET_RECRUITING

    London, EC1A 7BE, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • UC Irvine

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • UHKT Praha

    NOT_YET_RECRUITING

    Prague, 12800, Czechia

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, 9000, Belgium

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

    NOT_YET_RECRUITING

    Giessen, Hesse, 35392, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    NOT_YET_RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitair ziekenhuis Antwerpen UZA

    NOT_YET_RECRUITING

    Edegem, Antwerp, 2650, Belgium

  • University of Cincinnati Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Vall d'Hebron Institut d'Oncologia

    NOT_YET_RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Zealand University Hospital

    NOT_YET_RECRUITING

    Roskilde, 4000, Denmark

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Other studies related to the condition(s) this trial covers.