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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór krwi typu: białaczka limfocytarna, szpiczak plazmocytowy, chłoniak nieziarniczy lub białaczka limfoblastyczna
- •Leczenie terapią CAR-T (co najmniej 2 miesiące temu) lub terapią TCE (co najmniej 1 miesiąc temu)
- •Udokumentowana poprawa stanu po zastosowanej terapii
- •Niska lub bardzo niska ilość immunoglobulin G (przeciwciał) we krwi lub już otrzymywanie uzupełniającego leczenia immunoglobulinami
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (60)
UC Irvine
Orange, United States
CBCI, Colorado Blood Cancer Institute
Denver, United States
SSAK Partners
Coral Springs, United States
Mayo Clinic - Jacksonville
Jacksonville, United States
Indiana University Health Arnett, Inc.
Lafayette, United States
Johns Hopkins Asthma & Allergy Center
Baltimore, United States
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Bethesda, United States
Hackensack Meridian Health
Hackensack, United States
Carol G Simon Cancer Center
Morristown, United States
David H. Koch Center for Cancer Care
New York, United States
Montefiore Medical Center PRIME
The Bronx, United States
Duke University
Durham, United States
University of Cincinnati Medical Center
Cincinnati, United States
Penn State Hershey Medical Center
Hershey, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Fred Hutchinson Cancer Research Center
Seattle, United States
Medical College of Wisconsin
Milwaukee, United States
Universitair ziekenhuis Antwerpen UZA
Edegem, Belgium
AZ Delta
Roeselare, Belgium
UZ Gent
Ghent, Belgium
CHU de Liège
Liège, Belgium
Horizon Health Network
Fredericton, Canada
McGill University Health Research Institute
Montreal, Canada
FH Ostrova
Ostrova, Czechia
FH Hradec Kralove
Hradec Králové, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
UHKT Praha
Prague, Czechia
Department of Medicine, Vejle Hospital
Vejle, Denmark
Rigshospitalet
Copenhagen, Denmark
Zealand University Hospital
Roskilde, Denmark
CHU Rennes - Hopital Pontchaillou
Rennes, France
CHU de Nantes-Hotel Dieu
Nantes, France
CHU Angers - Hôpital Hôtel Dieu
Angers, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, France
Centre Henri Becquerel
Rouen, France
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
Fondazione Policlinico Universitario A. gemelli, IRCCS
Rome, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari)
Brescia, Italy
Ospedale di Circolo Fondazione Macchi
Varese, Italy
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
Candiolo, 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, Poland
Pratia MCM Krakow
Krakow, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Gliwice, Poland
Pratia Onkologia Katowice
Katowice, Poland
Aidport sp z o.o.
Skorzewo (Poznan), Poland
Hospital Universitario del Vinalopó
Elche, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Vall d'Hebron Institut d'Oncologia
Barcelona, Spain
Pratia ES HLA Hospital Universitario Moncloa
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hammersmith Hospital
London, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Trial contact
Trial Registration Coordinator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.
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