IgPro20: IgPro20 infusion administered SC.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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