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
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
Interventions
IgPro20
Conditions
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