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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

4. september 2026 oppdatert av: CSL Behring

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

63

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Ghent, Belgia, 9000
        • Har ikke rekruttert ennå
        • UZ Gent
      • Liège, Belgia, 4000
        • Har ikke rekruttert ennå
        • CHU de Liege
    • Antwerp
      • Edegem, Antwerp, Belgia, 2650
        • Har ikke rekruttert ennå
        • Universitair ziekenhuis Antwerpen UZA
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgia, 8800
        • Har ikke rekruttert ennå
        • AZ Delta
  • Canada
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5N5
        • Har ikke rekruttert ennå
        • Horizon Health Network
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Har ikke rekruttert ennå
        • McGill University Health Research Institute
  • Danmark
      • Copenhagen, Danmark, 2100
        • Avsluttet
        • Rigshospitalet
      • Roskilde, Danmark, 4000
        • Har ikke rekruttert ennå
        • Zealand University Hospital
    • South Region Denmark
      • Vejle, South Region Denmark, Danmark, 7100
        • Har ikke rekruttert ennå
        • Department of Medicine, Vejle Hospital
  • Forente stater
    • California
      • Orange, California, Forente stater, 92868
        • Har ikke rekruttert ennå
        • UC Irvine
    • Colorado
      • Denver, Colorado, Forente stater, 80218
        • Har ikke rekruttert ennå
        • CBCI, Colorado Blood Cancer Institute
    • Florida
      • Coral Springs, Florida, Forente stater, 33065
        • Rekruttering
        • SSAK Partners
      • Jacksonville, Florida, Forente stater, 32224
        • Har ikke rekruttert ennå
        • Mayo Clinic - Jacksonville
    • Indiana
      • Lafayette, Indiana, Forente stater, 47904
        • Har ikke rekruttert ennå
        • Indiana University Health Arnett, Inc.
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Har ikke rekruttert ennå
        • Johns Hopkins Asthma & Allergy Center
      • Bethesda, Maryland, Forente stater, 20817
        • Rekruttering
        • American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Har ikke rekruttert ennå
        • Hackensack Meridian Health
      • Morristown, New Jersey, Forente stater, 07960
        • Har ikke rekruttert ennå
        • Carol G Simon Cancer Center
    • New York
      • New York, New York, Forente stater, 10065
        • Har ikke rekruttert ennå
        • David H. Koch Center for Cancer Care
      • The Bronx, New York, Forente stater, 10467
        • Har ikke rekruttert ennå
        • Montefiore Medical Center PRIME
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Har ikke rekruttert ennå
        • Duke University
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Har ikke rekruttert ennå
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • Har ikke rekruttert ennå
        • Penn State Hershey Medical Center
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Har ikke rekruttert ennå
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Har ikke rekruttert ennå
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Har ikke rekruttert ennå
        • Medical College of Wisconsin
  • Frankrike
      • Rouen, Frankrike, 76038
        • Har ikke rekruttert ennå
        • Centre Henri Becquerel
    • ILE ET Vilaine
      • Rennes, ILE ET Vilaine, Frankrike, 35033
        • Har ikke rekruttert ennå
        • CHU Rennes - Hôpital Pontchaillou
    • Loire Atlantique
      • Nantes, Loire Atlantique, Frankrike, 44093
        • Har ikke rekruttert ennå
        • CHU de Nantes-Hotel Dieu
    • Maine Et Loire
      • Angers, Maine Et Loire, Frankrike, 49933 Angers Cedex 09
        • Har ikke rekruttert ennå
        • Chu Angers - Hôpital Hôtel Dieu
    • Vendée
      • La Roche-sur-Yon, Vendée, Frankrike, 85925
        • Har ikke rekruttert ennå
        • Centre Hospitalier Departemental Les Oudairies
  • Italia
      • Catania, Italia, 95124
        • Har ikke rekruttert ennå
        • Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)
      • Florence, Italia, 50134
        • Har ikke rekruttert ennå
        • Azienda Ospedaliera Universitaria Careggi
      • Milan, Italia, 20122
        • Har ikke rekruttert ennå
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Milan, Italia, 20132
        • Har ikke rekruttert ennå
        • Ospedale San Raffaele
    • Lazio
      • Rome, Lazio, Italia, 00168
        • Har ikke rekruttert ennå
        • Fondazione Policlinico Universitario A. gemelli, IRCCS
    • Lombardy
      • Brescia, Lombardy, Italia, 25123
        • Har ikke rekruttert ennå
        • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari)
      • Varese, Lombardy, Italia, 21100
        • Har ikke rekruttert ennå
        • Ospedale di Circolo Fondazione Macchi
    • Torino
      • Candiolo, Torino, Italia, 10060
        • Har ikke rekruttert ennå
        • Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
  • Polen
    • Kuyavian-Pomeranian Voivodeship
      • Torun, Kuyavian-Pomeranian Voivodeship, Polen, 87100
        • Har ikke rekruttert ennå
        • MICS Centrum Medyczne Toruń
    • Małopolska
      • Krakow, Małopolska, Polen, 30224
        • Har ikke rekruttert ennå
        • Pratia MCM Krakow
    • Sielesia
      • Gliwice, Sielesia, Polen, 44102
        • Har ikke rekruttert ennå
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40519
        • Har ikke rekruttert ennå
        • Pratia Onkologia Katowice
    • Wielkopolska
      • Skorzewo (Poznan), Wielkopolska, Polen, 60185
        • Har ikke rekruttert ennå
        • Aidport sp z o.o.
  • Spania
      • Madrid, Spania, 28040
        • Har ikke rekruttert ennå
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spania, 28008
        • Har ikke rekruttert ennå
        • Pratia ES HLA Hospital Universitario Moncloa
    • Alicante
      • Elche, Alicante, Spania, 3560
        • Har ikke rekruttert ennå
        • Hospital Universitario del Vinalopó
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • Har ikke rekruttert ennå
        • Hospital Universitari Germans Trias i Pujol
    • Barcelona/Catalonia
      • Barcelona, Barcelona/Catalonia, Spania, 08034
        • Har ikke rekruttert ennå
        • Hospital Clinic de Barcelona
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Har ikke rekruttert ennå
        • Hospital Universitario Marqués de Valdecilla
    • Catalonia
      • Barcelona, Catalonia, Spania, 08035
        • Har ikke rekruttert ennå
        • Vall d'Hebron Institut d'Oncologia
  • Storbritannia
      • London, Storbritannia, EC1A 7BE
        • Har ikke rekruttert ennå
        • St Bartholomew's Hospital
    • Greater London
      • London, Greater London, Storbritannia, W12 0HS
        • Har ikke rekruttert ennå
        • Hammersmith Hospital
    • Leicestershire
      • Leicester, Leicestershire, Storbritannia, LE1 5WW
        • Har ikke rekruttert ennå
        • Leicester Royal Infirmary
  • Tsjekkia
      • Prague, Tsjekkia, 10034
        • Har ikke rekruttert ennå
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tsjekkia, 12800
        • Har ikke rekruttert ennå
        • UHKT Praha
    • CZE
      • Ostrova, CZE, Tsjekkia, 70852
        • Har ikke rekruttert ennå
        • FH Ostrova
    • Hradec Králové Region
      • Hradec Králové, Hradec Králové Region, Tsjekkia, 50005
        • Har ikke rekruttert ennå
        • FH Hradec Kralove
  • Tyskland
    • Hesse
      • Giessen, Hesse, Tyskland, 35392
        • Har ikke rekruttert ennå
        • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Tyskland, 55131
        • Har ikke rekruttert ennå
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: IgPro20
IgPro20 infusion administered SC.
Andre navn:
  • Immune Globulin Subcutaneous (Human) 20% Liquid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Serious Bacterial Infections (SBIs) per Participant
Tidsramme: Up to Month 12
The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
Up to Month 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Infections per Participant
Tidsramme: Up to Month 12
Up to Month 12
Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant
Tidsramme: Up to Month 12
As per CTCAE, Grade 3 is defined as Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden). Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to adverse event. Infections of CTCAE Grade 3 or worse will be reported.
Up to Month 12
Number of Days Hospitalized due to Infections
Tidsramme: Up to Month 12
Up to Month 12
Number of Days With Anti-infectives Use
Tidsramme: Up to Month 12
Up to Month 12
Number of Infection-related Deaths and Complications
Tidsramme: Up to Month 12
Up to Month 12
Number of Infection-related Requirement for Intravenous (IV) Therapy
Tidsramme: Up to Month 12
Up to Month 12
Number of Infection-related Requirement for Hospitalization per Participant
Tidsramme: Up to Month 12
Up to Month 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Infusion Site Reaction and Other Local Reactions
Tidsramme: Up to Month 12

In this study, thromboembolic events are treated as AESIs.

The following 3 narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) queries are used for TEE evaluation:

  • Embolic and thrombotic events, arterial
  • Embolic and thrombotic events, venous
  • Embolic and thrombotic events, vessel type unspecified, and mixed arterial and venous.
Up to Month 12
Trough Concentrations of Serum IgG
Tidsramme: Up to Week 56
Up to Week 56
Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t])
Tidsramme: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Maximal Serum Concentration (Cmax) of IgG
Tidsramme: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Time to Maximal Serum Concentration (Tmax) of IgG
Tidsramme: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)
Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CSL Behring

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. september 2026

Primær fullføring (Antatt)

13. mars 2029

Studiet fullført (Antatt)

13. mars 2029

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IgPro20_3013
  • 2026-525626-38-00 (Registeridentifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

IPD-delingstidsramme

Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere