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
| Registry | NCT07648264 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 63 (Estimated) |
| Sponsor | CSL Behring (Industry) |
| Conditions | Secondary Immune Deficiency |
| Interventions | IgPro20 (Biological) |
| Dates | start 2026-09-15, primary completion 2029-09-27 (estimated), completion 2029-09-27 (estimated), first posted 2026-06-15, last updated 2026-10-14 |
| Locations | 60 sites in United States, Belgium, Canada, Czechia, Denmark, France, Germany, Italy and 3 more countries |
Related Papers Related Patents Related Grants Related Experts
All trials for Secondary Immune Deficiency All trials of IgPro20
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| IgPro20 | Experimental | Biological: IgPro20 | In 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| UC Irvine | Orange, California | United States | Not yet recruiting |
| CBCI, Colorado Blood Cancer Institute | Denver, Colorado | United States | Not yet recruiting |
| SSAK Partners | Coral Springs, Florida | United States | Recruiting |
| Mayo Clinic - Jacksonville | Jacksonville, Florida | United States | Not yet recruiting |
| Indiana University Health Arnett, Inc. | Lafayette, Indiana | United States | Not yet recruiting |
| Johns Hopkins Asthma & Allergy Center | Baltimore, Maryland | United States | Not yet recruiting |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders | Bethesda, Maryland | United States | Recruiting |
| Hackensack Meridian Health | Hackensack, New Jersey | United States | Not yet recruiting |
| Carol G Simon Cancer Center | Morristown, New Jersey | United States | Not yet recruiting |
| David H. Koch Center for Cancer Care | New York, New York | United States | Not yet recruiting |
| Montefiore Medical Center PRIME | The Bronx, New York | United States | Not yet recruiting |
| Duke University | Durham, North Carolina | United States | Not yet recruiting |
| University of Cincinnati Medical Center | Cincinnati, Ohio | United States | Not yet recruiting |
| Penn State Hershey Medical Center | Hershey, Pennsylvania | United States | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center | Houston, Texas | United States | Not yet recruiting |
| Fred Hutchinson Cancer Research Center | Seattle, Washington | United States | Not yet recruiting |
| Medical College of Wisconsin | Milwaukee, Wisconsin | United States | Not yet recruiting |
| Universitair ziekenhuis Antwerpen UZA | Edegem, Antwerp | Belgium | Not yet recruiting |
| AZ Delta | Roeselare, West-Vlaanderen | Belgium | Not yet recruiting |
| UZ Gent | Ghent | Belgium | Not yet recruiting |
| CHU de Liège | Liège | Belgium | Not yet recruiting |
| Horizon Health Network | Fredericton, New Brunswick | Canada | Not yet recruiting |
| McGill University Health Research Institute | Montreal, Quebec | Canada | Not yet recruiting |
| FH Ostrova | Ostrova, CZE | Czechia | Not yet recruiting |
| FH Hradec Kralove | Hradec Králové, Hradec Králové Region | Czechia | 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 | Denmark | Not yet recruiting |
| Rigshospitalet | Copenhagen | Denmark | Terminated |
| Zealand University Hospital | Roskilde | Denmark | Not yet recruiting |
| CHU Rennes - Hopital Pontchaillou | Rennes, ILE ET Vilaine | France | Not yet recruiting |
| CHU de Nantes-Hotel Dieu | Nantes, Loire Atlantique | France | Not yet recruiting |
| CHU Angers - Hôpital Hôtel Dieu | Angers, Maine Et Loire | France | Not yet recruiting |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon, Vendée | France | Not yet recruiting |
| Centre Henri Becquerel | Rouen | France | Not yet recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Giessen, Hesse | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz, Rhineland-Palatinate | Germany | Not yet recruiting |
| Fondazione Policlinico Universitario A. gemelli, IRCCS | Rome, Lazio | Italy | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari) | Brescia, Lombardy | Italy | Not yet recruiting |
| Ospedale di Circolo Fondazione Macchi | Varese, Lombardy | Italy | Not yet recruiting |
| Fondazione del Piemonte per l'Oncologia IRCCS Candiolo | Candiolo, Torino | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico) | Catania | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy | Not yet recruiting |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | Italy | Not yet recruiting |
| Ospedale San Raffaele | Milan | Italy | Not yet recruiting |
| MICS Centrum Medyczne Torun | Torun, Kuyavian-Pomeranian Voivodeship | Poland | Not yet recruiting |
| Pratia MCM Krakow | Krakow, Małopolska | Poland | Not yet recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy | Gliwice, Sielesia | Poland | Not yet recruiting |
| Pratia Onkologia Katowice | Katowice, Silesian Voivodeship | Poland | Not yet recruiting |
| Aidport sp z o.o. | Skorzewo (Poznan), Wielkopolska | Poland | Not yet recruiting |
| Hospital Universitario del Vinalopó | Elche, Alicante | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona | Barcelona, Barcelona/Catalonia | Spain | Not yet recruiting |
| Hospital Universitari Germans Trias i Pujol | Badalona, Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Marques de Valdecilla | Santander, Cantabria | Spain | Not yet recruiting |
| Vall d'Hebron Institut d'Oncologia | Barcelona, Catalonia | Spain | Not yet recruiting |
| Pratia ES HLA Hospital Universitario Moncloa | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | Not yet recruiting |
| Hammersmith Hospital | London, Greater London | United Kingdom | Not yet recruiting |
| Leicester Royal Infirmary | Leicester, Leicestershire | United Kingdom | Not yet recruiting |
| St Bartholomew's Hospital | London | United Kingdom | Not yet recruiting |