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NCT07648264RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
63 (estimated)
First submitted
10 Jun 2026
Start date
15 Sept 2026
Primary completion date
27 Sept 2029
Lead sponsor
CSL Behring
NCT number
NCT07648264
EU CT number
2026-525626-38-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 63
  • From 15 Sept 2026 to the primary completion date, 27 Sept 2029
  • 60 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of thromboembolic event (TEE) within 6 months before Screening.
  • Participants on any prohibited therapies, including anti-infective treatments.
  • 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.

Other illness

  • 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.
  • Presence of any systemic active infection at Screening.

Lab values

  • 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.

Other

  • Eastern Cooperative Oncology Group performance status \> 1.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Antwerpen (Uza)
Coordinator of this site? Confirm its status
EdegemBelgiumNot yet recruiting
UZ Gent
Coordinator of this site? Confirm its status
GhentBelgiumNot yet recruiting
CHU de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumNot yet recruiting
AZ Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumNot yet recruiting
Horizon Health Network
Coordinator of this site? Confirm its status
FrederictonCanadaNot yet recruiting
McGill University Health Research Institute
Coordinator of this site? Confirm its status
MontrealCanadaNot yet recruiting
FH Hradec Kralove
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Hradec KrálovéCzechiaNot yet recruiting
FH Ostrova
Coordinator of this site? Confirm its status
OstrovaCzechiaNot yet recruiting
Fakultni nemocnice Kralovske Vinohrady
Coordinator of this site? Confirm its status
PragueCzechiaNot yet recruiting
UHKT Praha
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PragueCzechiaNot yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Coordinator of this site? Confirm its status
GiessenGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Coordinator of this site? Confirm its status
MainzGermanyNot yet recruiting
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkTerminated
Zealand University Hospital
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RoskildeDenmarkNot yet recruiting
Department of Medicine, Vejle Hospital
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VejleDenmarkNot yet recruiting
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Vall d'Hebron Institut d'Oncologia
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BarcelonaSpainNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital Universitario del Vinalopo
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ElcheSpainNot yet recruiting
Pratia ES HLA Hospital Universitario Moncloa
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MadridSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainNot yet recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainNot yet recruiting
CHU Angers - Hôpital Hôtel Dieu#
Coordinator of this site? Confirm its status
AngersFranceNot yet recruiting
Centre Hospitalier Départemental Les Oudairies
Coordinator of this site? Confirm its status
La Roche-sur-YonFranceNot yet recruiting
CHU de Nantes - Hôtel Dieu
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NantesFranceNot yet recruiting
CHU Rennes - Hopital Pontchaillou
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RennesFranceNot yet recruiting
Centre Henri Becquerel
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RouenFranceNot yet recruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomNot yet recruiting
St. Bartholomew's Hospital
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LondonUnited KingdomNot yet recruiting
Hammersmith Hospital
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LondonUnited KingdomNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari)
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BresciaItalyNot yet recruiting
Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
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CandioloItalyNot yet recruiting
Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)
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CataniaItalyNot yet recruiting
Azienda Ospedaliera Universitaria Careggi
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FlorenceItalyNot yet recruiting
Ospedale San Raffaele
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MilanItalyNot yet recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyNot yet recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyNot yet recruiting
Ospedale di Circolo Fondazione Macchi
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VareseItalyNot yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandNot yet recruiting
Pratia Onkologia Katowice
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KatowicePolandNot yet recruiting
Pratia MCM Krakow
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KrakowPolandNot yet recruiting
Aidport sp z o.o.
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Skorzewo (Poznan)PolandNot yet recruiting
Mics Centrum Medyczne Torun
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TorunPolandNot yet recruiting
Johns Hopkins Asthma & Allergy Center
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BaltimoreUnited StatesNot yet recruiting
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
University of Cincinnati Medical Center
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CincinnatiUnited StatesNot yet recruiting
SSAK Partners
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Coral SpringsUnited StatesRecruiting
CBCI, Colorado Blood Cancer Institute
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DenverUnited StatesNot yet recruiting
Duke University
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DurhamUnited StatesNot yet recruiting
Hackensack Meridian Health
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HackensackUnited StatesNot yet recruiting
Penn State Hershey Medical Center
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HersheyUnited StatesNot yet recruiting
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesNot yet recruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesNot yet recruiting
Indiana University Health Arnett, Inc.
Coordinator of this site? Confirm its status
LafayetteUnited StatesNot yet recruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesNot yet recruiting
Carol G Simon Cancer Center
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MorristownUnited StatesNot yet recruiting
David H. Koch Center for Cancer Care
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
UC Irvine
Coordinator of this site? Confirm its status
OrangeUnited StatesNot yet recruiting
Fred Hutchinson Cancer Research Center
Coordinator of this site? Confirm its status
SeattleUnited StatesNot yet recruiting
Montefiore Medical Center Prime
Coordinator of this site? Confirm its status
The BronxUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.