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NOT YET RECRUITING

NCT07648264

PHASE3

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

Sponsor: CSL Behring

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-24

Completion Date

2029-02-16

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Secondary Immune Deficiency

Interventions

BIOLOGICAL

IgPro20

IgPro20 infusion administered SC.

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.

Locations (60)

UC Irvine

Orange, California, United States

CBCI, Colorado Blood Cancer Institute

Denver, Colorado, United States

SSAK Partners

Coral Springs, Florida, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Indiana University Health Arnett, Inc.

Lafayette, Indiana, United States

Johns Hopkins Asthma & Allergy Center

Baltimore, Maryland, United States

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

Bethesda, Maryland, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Carol G Simon Cancer Center

Morristown, New Jersey, United States

David H. Koch Center for Cancer Care

New York, New York, United States

Montefiore Medical Center PRIME

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Universitair ziekenhuis Antwerpen UZA

Edegem, Antwerp, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

UZ Gent

Ghent, Belgium

CHU de Liège

Liège, Belgium

Horizon Health Network

Fredericton, New Brunswick, Canada

McGill University Health Research Institute

Montreal, Quebec, Canada

FH Ostrova

Ostrova, CZE, Czechia

FH Hradec Kralove

Hradec Králové, Hradec Králové Region, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

UHKT Praha

Prague, Czechia

Department of Medicine, Vejle Hospital

Vejle, South Region Denmark, Denmark

Rigshospitalet

Copenhagen, Denmark

Zealand University Hospital

Roskilde, Denmark

CHU Rennes - Hopital Pontchaillou

Rennes, ILE ET Vilaine, France

CHU de Nantes-Hotel Dieu

Nantes, Loire Atlantique, France

CHU Angers - Hôpital Hôtel Dieu

Angers, Maine Et Loire, France

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, Vendée, France

Centre Henri Becquerel

Rouen, France

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, Hesse, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate, Germany

Fondazione Policlinico Universitario A. gemelli, IRCCS

Rome, Lazio, Italy

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

Brescia, Lombardy, Italy

Ospedale di Circolo Fondazione Macchi

Varese, Lombardy, Italy

Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

Candiolo, Torino, Italy

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

Catania, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Italy

Ospedale San Raffaele

Milan, Italy

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Pratia MCM Krakow

Krakow, Małopolska, Poland

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

Gliwice, Sielesia, Poland

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, Poland

Aidport sp z o.o.

Skorzewo (Poznan), Wielkopolska, Poland

Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Hospital Clinic de Barcelona

Barcelona, Barcelona/Catalonia, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Vall d'Hebron Institut d'Oncologia

Barcelona, Catalonia, Spain

Pratia ES HLA Hospital Universitario Moncloa

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hammersmith Hospital

London, Greater London, United Kingdom

Leicester Royal Infirmary

Leicester, Leicestershire, United Kingdom

St Bartholomew's Hospital

London, United Kingdom