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AzTrials

Secondary Immune DeficiencyPhase 3NCT07648264

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

A Phase 3 study testing IgPro20 in people with Secondary Immune Deficiency, run by CSL Behring at 60 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, multicenter, open-label, single-arm study to assess the efficacy, safety, and pharmacokinetics (PK) of IgPro20 in adults with hematologic malignancies treated with B-cell targeting Chimeric antigen receptor T-cell (CAR T-cell) and T-cell redirecting therapies (such as T-cell engager bispecific… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Secondary Immune Deficiency
What is being tested?
IgPro20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
60 sitesin 11 countries
Study dates
15 Sep 2026to 27 Sep 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • 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:
Show all 14Show fewer
  • CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria
  • MM based on International Myeloma Working Group response criteria
  • NHL based on Lugano Classification criteria
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

60 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Trial Registration Coordinator contact

+16108784697

clinicaltrials@cslbehring.com

60 sites in 11 countries

United States17 sites, 17 recruiting

  • Johns Hopkins Asthma & Allergy Center

    Baltimore, Maryland, 21224

    Not yet recruiting

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

    Bethesda, Maryland, 20817

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Not yet recruiting

  • SSAK Partners

    Coral Springs, Florida, 33065

    Recruiting

  • CBCI, Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Not yet recruiting

  • Duke University

    Durham, North Carolina, 27710

    Not yet recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Not yet recruiting

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Not yet recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Not yet recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

    Not yet recruiting

  • Indiana University Health Arnett, Inc.

    Lafayette, Indiana, 47904

    Not yet recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Not yet recruiting

  • Carol G Simon Cancer Center

    Morristown, New Jersey, 07960

    Not yet recruiting

  • David H. Koch Center for Cancer Care

    New York, New York, 10065

    Not yet recruiting

  • UC Irvine

    Orange, California, 92868

    Not yet recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

    Not yet recruiting

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467

    Not yet recruiting

Other trials in United States

Italy8 sites, 8 recruiting

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

    Brescia, Lombardy, 25123

    Not yet recruiting

  • Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

    Candiolo, Torino, 10060

    Not yet recruiting

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

    Catania, 95124

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    Not yet recruiting

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Not yet recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Not yet recruiting

  • Fondazione Policlinico Universitario A. gemelli, IRCCS

    Rome, Lazio, 00168

    Not yet recruiting

  • Ospedale di Circolo Fondazione Macchi

    Varese, Lombardy, 21100

    Not yet recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Not yet recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona/Catalonia, 08034

    Not yet recruiting

  • Vall d'Hebron Institut d'Oncologia

    Barcelona, Catalonia, 08035

    Not yet recruiting

  • Hospital Universitario del Vinalopó

    Elche, Alicante, 3560

    Not yet recruiting

  • Pratia ES HLA Hospital Universitario Moncloa

    Madrid, 28008

    Not yet recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Not yet recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Not yet recruiting

Other trials in Spain

France5 sites, 5 recruiting

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, Maine Et Loire, 49933 Angers Cedex 09

    Not yet recruiting

  • Centre Hospitalier Départemental Les Oudairies

    La Roche-sur-Yon, Vendée, 85925

    Not yet recruiting

  • CHU de Nantes-Hotel Dieu

    Nantes, Loire Atlantique, 44093

    Not yet recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes, ILE ET Vilaine, 35033

    Not yet recruiting

  • Centre Henri Becquerel

    Rouen, 76038

    Not yet recruiting

Other trials in France

Poland5 sites, 5 recruiting

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

    Gliwice, Sielesia, 44102

    Not yet recruiting

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40519

    Not yet recruiting

  • Pratia MCM Krakow

    Krakow, Małopolska, 30224

    Not yet recruiting

  • Aidport sp z o.o.

    Skorzewo (Poznan), Wielkopolska, 60185

    Not yet recruiting

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship, 87100

    Not yet recruiting

Other trials in Poland

Belgium4 sites, 4 recruiting

  • Universitair ziekenhuis Antwerpen UZA

    Edegem, Antwerp, 2650

    Not yet recruiting

  • UZ Gent

    Ghent, 9000

    Not yet recruiting

  • CHU de Liège

    Liège, 4000

    Not yet recruiting

  • AZ Delta

    Roeselare, West-Vlaanderen, 8800

    Not yet recruiting

Other trials in Belgium

Czechia4 sites, 4 recruiting

  • FH Hradec Kralove

    Hradec Králové, Hradec Králové Region, 50005

    Not yet recruiting

  • FH Ostrova

    Ostrova, CZE, 70852

    Not yet recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

    Not yet recruiting

  • UHKT Praha

    Prague, 12800

    Not yet recruiting

Other trials in Czechia

Denmark3 sites, 2 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Terminated

  • Zealand University Hospital

    Roskilde, 4000

    Not yet recruiting

  • Department of Medicine, Vejle Hospital

    Vejle, South Region Denmark, 7100

    Not yet recruiting

Other trials in Denmark

United Kingdom3 sites, 3 recruiting

  • Leicester Royal Infirmary

    Leicester, Leicestershire, LE1 5WW

    Not yet recruiting

  • Hammersmith Hospital

    London, Greater London, W12 0HS

    Not yet recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Not yet recruiting

Other trials in United Kingdom

Canada2 sites, 2 recruiting

  • Horizon Health Network

    Fredericton, New Brunswick, E3B 5N5

    Not yet recruiting

  • McGill University Health Research Institute

    Montreal, Quebec, H4A 3J1

    Not yet recruiting

Other trials in Canada

Germany2 sites, 2 recruiting

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

    Giessen, Hesse, 35392

    Not yet recruiting

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

    Not yet recruiting

Other trials in Germany

About this study

Official title: A Phase 3, Prospective, Open-label, Multicenter, Single-arm Study to Investigate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Subjects With Secondary Immune Deficiency Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies

This is a prospective, multicenter, open-label, single-arm study to assess the efficacy, safety, and pharmacokinetics (PK) of IgPro20 in adults with hematologic malignancies treated with B-cell targeting Chimeric antigen receptor T-cell (CAR T-cell) and T-cell redirecting therapies (such as T-cell engager bispecific antibody [TCE BsAb] therapy). The primary objective is to demonstrate that true annualized rate of serious bacterial infection (SBIs) is less than (<) 1.0.

This study includes two cohorts:

  1. Loading Cohort: Participants with serum immunoglobulin G (IgG) < 500 milligrams per deciliter (mg/dL) at Screening, with or without ongoing immunoglobulin replacement therapy (IgRT) during Screening, who must have received five doses of IgPro20 during the Initial Treatment Period.
  2. Maintenance-only Cohort: Participants with serum IgG greater than or equal to (≥) 500 mg/dL and ongoing IgRT at Screening, who must have received one dose of IgPro20 during the Initial Treatment Period.
Being tested
IgPro20
Keywords
Hematologic Malignancies, B-cell acute lymphoblastic leukemia (B-ALL), Multiple myeloma (MM), Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Non-Hodgkin lymphomas (NHL), T-cell engager bispecific antibody (TCE BsAb) therapy, Hypogammaglobulinemia, Lowered serum immunoglobulin levels
Medical subject headings
Hematologic Neoplasms, Burkitt Lymphoma, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Agammaglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IgPro20Biological

    Also called Immune Globulin Subcutaneous (Human) 20% Liquid

    IgPro20 infusion administered SC.

Study groups in NCT07648264
Study groupRoleWhat they receive
IgPro20ExperimentalIn the loading cohort, participants will receive a loading dose of IgPro20 subcutaneously (SC) once daily for five consecutive days during the first week (Initial Treatment Period), followed by SC infusion weekly dosing for a total treatment duration of 52 weeks. In the maintenance-only cohort, participants will receive weekly doses of IgPro20 SC infusion for a total treatment duration of 52 weeks.
Receives: Biological: IgPro20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Serious Bacterial Infections (SBIs) per Participant

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

    Measured: Up to Month 12

Secondary outcomes (12)

  1. Number of Infections per Participant

    Measured: Up to Month 12

  2. Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant

    As per CTCAE, Grade 3 is defined as Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to adverse event. Infections of CTCAE Grade 3 or worse will be reported.

    Measured: Up to Month 12

  3. Number of Days Hospitalized due to Infections

    Measured: Up to Month 12

  4. Number of Days With Anti-infectives Use

    Measured: Up to Month 12

  5. Number of Infection-related Deaths and Complications

    Measured: Up to Month 12

  6. Number of Infection-related Requirement for Intravenous (IV) Therapy

    Measured: Up to Month 12

  7. Number of Infection-related Requirement for Hospitalization per Participant

    Measured: Up to Month 12

  8. Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Infusion Site Reaction and Other Local Reactions

    In this study, thromboembolic events are treated as AESIs.

    The following 3 narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) queries are used for TEE evaluation:

    • Embolic and thrombotic events, arterial
    • Embolic and thrombotic events, venous
    • Embolic and thrombotic events, vessel type unspecified, and mixed arterial and venous.

    Measured: Up to Month 12

  9. Trough Concentrations of Serum IgG

    Measured: Up to Week 56

  10. Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t])

    Measured: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)

  11. Maximal Serum Concentration (Cmax) of IgG

    Measured: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)

  12. Time to Maximal Serum Concentration (Tmax) of IgG

    Measured: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start15 Sep 2026
  3. Primary completion27 Sep 2029 (estimated)
  4. Study completion27 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is single group open-label study.
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648264
Sponsor's protocol ID
IgPro20_3013
Other IDs
2026-525626-38-00
Status last verified
Oct 2026
First submitted
10 Jun 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IgPro20 in people with Secondary Immune Deficiency, run by CSL Behring at 60 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Italy, Spain, France, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Registration Coordinator (+16108784697, clinicaltrials@cslbehring.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Serious Bacterial Infections (SBIs) per Participant (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07648264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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