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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IgPro20_30132026-525626-38-00
• Study Type: interventional
• Target: 63
• Locations: 11 countries
• Sites: 60

Brief 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. 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. 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.

Conditions

Secondary Immune Deficiency

Keywords

Hematologic Malignancies; B-cell acute lymphoblastic leukemia (B-ALL); Multiple myeloma (MM); Chronic lymphocytic leukemia (CLL); Small lymphocytic lymphoma (SLL); Non-Hodgkin lymphomas (NHL); T-cell engager bispecific antibody (TCE BsAb) therapy; Hypogammaglobulinemia; Lowered serum immunoglobulin levels

Outcome Measures

Primary Outcomes (1)

• Number of Serious Bacterial Infections (SBIs) per Participant

  The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.

  Up to Month 12

Secondary Outcomes (12)

• Number of Infections per Participant

  Up to Month 12

• Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant

  Up to Month 12

• Number of Days Hospitalized due to Infections

  Up to Month 12

• Number of Days With Anti-infectives Use

  Up to Month 12

• Number of Infection-related Deaths and Complications

  Up to Month 12

Study Arms (1)

IgPro20

EXPERIMENTAL

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.

Biological: IgPro20

Interventions

IgPro20 BIOLOGICAL

IgPro20 infusion administered SC.

Also known as: Immune Globulin Subcutaneous (Human) 20% Liquid

IgPro20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (60)

UC Irvine

Orange, California, 92868, United States

Location

CBCI, Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

SSAK Partners

Coral Springs, Florida, 33065, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Indiana University Health Arnett, Inc.

Lafayette, Indiana, 47904, United States

Location

Johns Hopkins Asthma & Allergy Center

Baltimore, Maryland, 21224, United States

Location

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

Bethesda, Maryland, 20817, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

Carol G Simon Cancer Center

Morristown, New Jersey, 07960, United States

Location

David H. Koch Center for Cancer Care

New York, New York, 10065, United States

Location

Montefiore Medical Center PRIME

The Bronx, New York, 10467, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitair ziekenhuis Antwerpen UZA

Edegem, Antwerp, 2650, Belgium

Location

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Horizon Health Network

Fredericton, New Brunswick, E3B 5N5, Canada

Location

McGill University Health Research Institute

Montreal, Quebec, H4A 3J1, Canada

Location

FH Ostrova

Ostrova, CZE, 70852, Czechia

Location

FH Hradec Kralove

Hradec Králové, Hradec Králové Region, 50005, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

UHKT Praha

Prague, 12800, Czechia

Location

Department of Medicine, Vejle Hospital

Vejle, South Region Denmark, 7100, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

CHU Rennes - Hopital Pontchaillou

Rennes, ILE ET Vilaine, 35033, France

Location

CHU de Nantes-Hotel Dieu

Nantes, Loire Atlantique, 44093, France

Location

CHU Angers - Hôpital Hôtel Dieu

Angers, Maine Et Loire, 49933 Angers Cedex 09, France

Location

Centre Hospitalier Départemental Les Oudairies

La Roche-sur-Yon, Vendée, 85925, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, Hesse, 35392, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Fondazione Policlinico Universitario A. gemelli, IRCCS

Rome, Lazio, 00168, Italy

Location

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

Brescia, Lombardy, 25123, Italy

Location

Ospedale di Circolo Fondazione Macchi

Varese, Lombardy, 21100, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

Candiolo, Torino, 10060, Italy

Location

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

Catania, 95124, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

MICS Centrum Medyczne Torun

Torun, Kuyavian-Pomeranian Voivodeship, 87100, Poland

Location

Pratia MCM Krakow

Krakow, Małopolska, 30224, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Gliwice, Sielesia, 44102, Poland

Location

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, 40519, Poland

Location

Aidport sp z o.o.

Skorzewo (Poznan), Wielkopolska, 60185, Poland

Location

Hospital Universitario del Vinalopó

Elche, Alicante, 3560, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona/Catalonia, 08034, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Vall d'Hebron Institut d'Oncologia

Barcelona, Catalonia, 08035, Spain

Location

Pratia ES HLA Hospital Universitario Moncloa

Madrid, 28008, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hammersmith Hospital

London, Greater London, W12 0HS, United Kingdom

Location

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Burkitt Lymphoma; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Agammaglobulinemia

Interventions

Hizentra; gamma-Globulins; Fluid Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Therapy; Therapeutics

Central Study Contacts

Trial Registration Coordinator

CONTACT

+16108784697; clinicaltrials@cslbehring.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is single group open-label study.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): February 16, 2029
• Study Completion (Estimated): February 16, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

CZ (4); PL (5); ES (7); FR (5); US (17); BE (4); DE (2); CA (2); DK (3); IT (8); GB (3)