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, 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
2 other identifiers
interventional
63
11 countries
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2026
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 13, 2029
September 21, 2026
September 1, 2026
2.5 years
June 10, 2026
September 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Serious Bacterial Infections (SBIs) per Participant
The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
Up to Month 12
Secondary Outcomes (12)
Number of Infections per Participant
Up to Month 12
Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant
Up to Month 12
Number of Days Hospitalized due to Infections
Up to Month 12
Number of Days With Anti-infectives Use
Up to Month 12
Number of Infection-related Deaths and Complications
Up to Month 12
- +7 more secondary outcomes
Study Arms (1)
IgPro20
EXPERIMENTALIn 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.
Interventions
IgPro20 infusion administered SC.
Eligibility Criteria
You may qualify if:
- 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:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (60)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- This is open-label study.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 15, 2026
Study Start
September 15, 2026
Primary Completion (Estimated)
March 13, 2029
Study Completion (Estimated)
March 13, 2029
Last Updated
September 21, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
- Access Criteria
- Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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.