Secondary Immune Deficiency

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 | PHASE 3 | INTERVENTIONAL

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 Peri

60 Sites

63 Participants

NOT YET RECRUITING

18 Years

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SUBMIT

UC Irvine

Orange,California,United States,92868

CBCI, Colorado Blood Cancer Institute

Denver,Colorado,United States,80218

SSAK Partners

Coral Springs,Florida,United States,33065

Mayo Clinic Jacksonville

Jacksonville,Florida,United States,32224

Indiana University Health Arnett, Inc.

Lafayette,Indiana,United States,47904

Johns Hopkins Asthma & Allergy Center

Baltimore,Maryland,United States,21224

American Oncology Partners, PA dba The Center for Cancer and Blood Disorders

Bethesda,Maryland,United States,20817

Hackensack Meridian Health

Hackensack,New Jersey,United States,07601

Carol G Simon Cancer Center

Morristown,New Jersey,United States,07960

David H. Koch Center for Cancer Care

New York,New York,United States,10065

Montefiore Medical Center PRIME

The Bronx,New York,United States,10467

Duke University

Durham,North Carolina,United States,27710

University of Cincinnati Medical Center

Cincinnati,Ohio,United States,45219

Penn State Hershey Medical Center

Hershey,Pennsylvania,United States,17033

The University of Texas MD Anderson Cancer Center

Houston,Texas,United States,77030

Fred Hutchinson Cancer Research Center

Seattle,Washington,United States,98109

Medical College of Wisconsin

Milwaukee,Wisconsin,United States,53226

Universitair ziekenhuis Antwerpen UZA

Edegem,Antwerp,Belgium,2650

AZ Delta

Roeselare,West-Vlaanderen,Belgium,8800

UZ Gent

Ghent,West-Vlaanderen,Belgium,9000

CHU de Lige

Liège,West-Vlaanderen,Belgium,4000

Horizon Health Network

Fredericton,New Brunswick,Canada,E3B5N5

McGill University Health Research Institute

Montreal,Quebec,Canada,H4A3J1

FH Ostrova

Ostrova,CZE,Czechia,70852

FH Hradec Kralove

Hradec Králové,Hradec Králové Region,Czechia,50005

Fakultni nemocnice Kralovske Vinohrady

Prague,Hradec Králové Region,Czechia,10034

UHKT Praha

Prague,Hradec Králové Region,Czechia,12800

Department of Medicine, Vejle Hospital

Vejle,South Region Denmark,Denmark,7100

Rigshospitalet

Copenhagen,South Region Denmark,Denmark,2100

Zealand University Hospital

Roskilde,South Region Denmark,Denmark,4000

CHU Rennes Hopital Pontchaillou

Rennes,ILE ET Vilaine,France,35033

CHU de NantesHotel Dieu

Nantes,Loire Atlantique,France,44093

CHU Angers Hpital Htel Dieu

Angers,Maine Et Loire,France,49933AngersCedex09

Centre Hospitalier Dpartemental Les Oudairies

La Roche-sur-Yon,Vendée,France,85925

Centre Henri Becquerel

Rouen,Vendée,France,76038

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen,Hesse,Germany,35392

Universitaetsmedizin der Johannes GutenbergUniversitaet Mainz

Mainz,Rhineland-Palatinate,Germany,55131

Fondazione Policlinico Universitario A. gemelli, IRCCS

Rome,Lazio,Italy,00168

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari)

Brescia,Lombardy,Italy,25123

Ospedale di Circolo Fondazione Macchi

Varese,Lombardy,Italy,21100

Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

Candiolo,Torino,Italy,10060

Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico San Marco" (Presidio G. Rodolico)

Catania,Torino,Italy,95124

Azienda Ospedaliera Universitaria Careggi

Florence,Torino,Italy,50134

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan,Torino,Italy,20122

Ospedale San Raffaele

Milan,Torino,Italy,20132

MICS Centrum Medyczne Torun

Torun,Kuyavian-Pomeranian Voivodeship,Poland,87100

Pratia MCM Krakow

Krakow,Małopolska,Poland,30224

Narodowy Instytut Onkologii im. Marii SklodowskiejCuriePanstwowy Instytut Badawczy

Gliwice,Sielesia,Poland,44102

Pratia Onkologia Katowice

Katowice,Silesian Voivodeship,Poland,40519

Aidport sp z o.o.

Skorzewo (Poznan),Wielkopolska,Poland,60185

Hospital Universitario del Vinalop

Elche,Alicante,Spain,3560

Hospital Clinic de Barcelona

Barcelona,Barcelona/Catalonia,Spain,08034

Hospital Universitari Germans Trias i Pujol

Badalona,Barcelona,Spain,08916

Hospital Universitario Marques de Valdecilla

Santander,Cantabria,Spain,39008

Vall d'Hebron Institut d'Oncologia

Barcelona,Catalonia,Spain,08035

Pratia ES HLA Hospital Universitario Moncloa

Madrid,Catalonia,Spain,28008

Hospital Universitario Fundacion Jimenez Diaz

Madrid,Catalonia,Spain,28040

Hammersmith Hospital

London,Greater London,United Kingdom,W120HS

Leicester Royal Infirmary

Leicester,Leicestershire,United Kingdom,LE15WW

St Bartholomew's Hospital

London,Leicestershire,United Kingdom,EC1A7BE

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov