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Clinical Trials in the UK / NCT07648264
Recruiting Phase 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

NCT07648264 · tracked via the Priya Life Science UK tracker
Sponsor
CSL Behring
Phase
Phase 3
Started
2026-09-11
Last updated
2026-09-09

Condition(s) studied

Secondary Immune Deficiency

Investigational drug(s) / intervention(s)

IgPro20

IgPro20: IgPro20 infusion administered SC.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
UC Irvine Orange California Not Yet Recruiting
CBCI, Colorado Blood Cancer Institute Denver Colorado Not Yet Recruiting
SSAK Partners Coral Springs Florida Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Not Yet Recruiting
Indiana University Health Arnett, Inc. Lafayette Indiana Not Yet Recruiting
Johns Hopkins Asthma & Allergy Center Baltimore Maryland Not Yet Recruiting
American Oncology Partners, PA dba The Center for Cancer and Blood Disorders Bethesda Maryland Recruiting
Hackensack Meridian Health Hackensack New Jersey Not Yet Recruiting
Carol G Simon Cancer Center Morristown New Jersey Not Yet Recruiting
David H. Koch Center for Cancer Care New York New York Not Yet Recruiting
Montefiore Medical Center PRIME The Bronx New York Not Yet Recruiting
Duke University Durham North Carolina Not Yet Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Not Yet Recruiting
Penn State Hershey Medical Center Hershey Pennsylvania Not Yet Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Not Yet Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Not Yet Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Not Yet Recruiting
Universitair ziekenhuis Antwerpen UZA Edegem Antwerp Not Yet Recruiting
AZ Delta Roeselare West-Vlaanderen Not Yet Recruiting
UZ Gent Ghent Belgium Not Yet Recruiting
CHU de Liège Liège Belgium Not Yet Recruiting
Horizon Health Network Fredericton New Brunswick Not Yet Recruiting
McGill University Health Research Institute Montreal Quebec Not Yet Recruiting
FH Ostrova Ostrova CZE Not Yet Recruiting
FH Hradec Kralove Hradec Králové Hradec Králové Region Not Yet Recruiting
Fakultni nemocnice Kralovske Vinohrady Prague Czechia Not Yet Recruiting
UHKT Praha Prague Czechia Not Yet Recruiting
Department of Medicine, Vejle Hospital Vejle South Region Denmark Not Yet Recruiting
Rigshospitalet Copenhagen Denmark Terminated
Zealand University Hospital Roskilde Denmark Not Yet Recruiting
CHU Rennes - Hopital Pontchaillou Rennes ILE ET Vilaine Not Yet Recruiting
CHU de Nantes-Hotel Dieu Nantes Loire Atlantique Not Yet Recruiting
CHU Angers - Hôpital Hôtel Dieu Angers Maine Et Loire Not Yet Recruiting
Centre Hospitalier Départemental Les Oudairies La Roche-sur-Yon Vendée Not Yet Recruiting
Centre Henri Becquerel Rouen France Not Yet Recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen Giessen Hesse Not Yet Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz Rhineland-Palatinate Not Yet Recruiting
Fondazione Policlinico Universitario A. gemelli, IRCCS Rome Lazio Not Yet Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari) Brescia Lombardy Not Yet Recruiting
Ospedale di Circolo Fondazione Macchi Varese Lombardy Not Yet Recruiting

+ 20 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07648264 on ClinicalTrials.gov ↗ ← All trials in the UK