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NCT07648264PHASE3Recruiting

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

CSL Behring

Start Date

9/15/2026

Completion Date

3/13/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

IgPro20

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Conditions

Secondary Immune Deficiency

Locations

UC Irvine

Orange, California 92868

United States

CBCI, Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

SSAK Partners

Coral Springs, Florida 33065

United States

Mayo Clinic - Jacksonville

Jacksonville, Florida 32224

United States

Indiana University Health Arnett, Inc.

Lafayette, Indiana 47904

United States

Johns Hopkins Asthma & Allergy Center

Baltimore, Maryland 21224

United States

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

Bethesda, Maryland 20817

United States

Hackensack Meridian Health

Hackensack, New Jersey 07601

United States

Carol G Simon Cancer Center

Morristown, New Jersey 07960

United States

David H. Koch Center for Cancer Care

New York, New York 10065

United States

Montefiore Medical Center PRIME

The Bronx, New York 10467

United States

Duke University

Durham, North Carolina 27710

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Penn State Hershey Medical Center

Hershey, Pennsylvania 17033

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Universitair ziekenhuis Antwerpen UZA

Edegem, Antwerp 2650

Belgium

AZ Delta

Roeselare, West-Vlaanderen 8800

Belgium

UZ Gent

Ghent, 9000

Belgium

CHU de Liège

Liège, 4000

Belgium

Horizon Health Network

Fredericton, New Brunswick E3B 5N5

Canada

McGill University Health Research Institute

Montreal, Quebec H4A 3J1

Canada

FH Ostrova

Ostrova, CZE 70852

Czechia

FH Hradec Kralove

Hradec Králové, Hradec Králové Region 50005

Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034

Czechia

UHKT Praha

Prague, 12800

Czechia

Department of Medicine, Vejle Hospital

Vejle, South Region Denmark 7100

Denmark

Rigshospitalet

Copenhagen, 2100

Denmark

Zealand University Hospital

Roskilde, 4000

Denmark

CHU Rennes - Hopital Pontchaillou

Rennes, ILE ET Vilaine 35033

France

CHU de Nantes-Hotel Dieu

Nantes, Loire Atlantique 44093

France

CHU Angers - Hôpital Hôtel Dieu

Angers, Maine Et Loire 49933 Angers Cedex 09

France

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, Vendée 85925

France

Centre Henri Becquerel

Rouen, 76038

France

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, Hesse 35392

Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate 55131

Germany

Fondazione Policlinico Universitario A. gemelli, IRCCS

Rome, Lazio 00168

Italy

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

Brescia, Lombardy 25123

Italy

Ospedale di Circolo Fondazione Macchi

Varese, Lombardy 21100

Italy

Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

Candiolo, Torino 10060

Italy

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

Catania, 95124

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122

Italy

Ospedale San Raffaele

Milan, 20132

Italy

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship 87100

Poland

Pratia MCM Krakow

Krakow, Małopolska 30224

Poland

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

Gliwice, Sielesia 44102

Poland

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship 40519

Poland

Aidport sp z o.o.

Skorzewo (Poznan), Wielkopolska 60185

Poland

Hospital Universitario del Vinalopó

Elche, Alicante 3560

Spain

Hospital Clinic de Barcelona

Barcelona, Barcelona/Catalonia 08034

Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39008

Spain

Vall d'Hebron Institut d'Oncologia

Barcelona, Catalonia 08035

Spain

Pratia ES HLA Hospital Universitario Moncloa

Madrid, 28008

Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040

Spain

Hammersmith Hospital

London, Greater London W12 0HS

United Kingdom

Leicester Royal Infirmary

Leicester, Leicestershire LE1 5WW

United Kingdom

St Bartholomew's Hospital

London, EC1A 7BE

United Kingdom