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, Recruiting, 63 participants, CSL Behring

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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

RegistryNCT07648264
StatusRecruiting
PhasePhase 3
Study typeInterventional; na, single group, masking: none, treatment
Enrollment63 (Estimated)
SponsorCSL Behring (Industry)
ConditionsSecondary Immune Deficiency
InterventionsIgPro20 (Biological)
Datesstart 2026-09-15, primary completion 2029-09-27 (estimated), completion 2029-09-27 (estimated), first posted 2026-06-15, last updated 2026-10-14
Locations60 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

-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. 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.

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+Arms and interventions

ArmTypeInterventionsDescription
IgPro20ExperimentalBiological: IgPro20In 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.
  • IgPro20 (Biological), also known as Immune Globulin Subcutaneous (Human) 20% Liquid: IgPro20 infusion administered SC.

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • 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]: 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.
  • 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]
  • Number of Infection-related Requirement for Intravenous (IV) Therapy [Up to Month 12]
  • Number of Infection-related Requirement for Hospitalization per Participant [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 [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.
  • Trough Concentrations of Serum IgG [Up to Week 56]
  • Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t]) [Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)]
  • Maximal Serum Concentration (Cmax) of IgG [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 [Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)]

+Eligibility

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.

+Locations (60)

FacilityCityCountryStatus
UC IrvineOrange, CaliforniaUnited StatesNot yet recruiting
CBCI, Colorado Blood Cancer InstituteDenver, ColoradoUnited StatesNot yet recruiting
SSAK PartnersCoral Springs, FloridaUnited StatesRecruiting
Mayo Clinic - JacksonvilleJacksonville, FloridaUnited StatesNot yet recruiting
Indiana University Health Arnett, Inc.Lafayette, IndianaUnited StatesNot yet recruiting
Johns Hopkins Asthma & Allergy CenterBaltimore, MarylandUnited StatesNot yet recruiting
American Oncology Partners, PA dba The Center for Cancer and Blood DisordersBethesda, MarylandUnited StatesRecruiting
Hackensack Meridian HealthHackensack, New JerseyUnited StatesNot yet recruiting
Carol G Simon Cancer CenterMorristown, New JerseyUnited StatesNot yet recruiting
David H. Koch Center for Cancer CareNew York, New YorkUnited StatesNot yet recruiting
Montefiore Medical Center PRIMEThe Bronx, New YorkUnited StatesNot yet recruiting
Duke UniversityDurham, North CarolinaUnited StatesNot yet recruiting
University of Cincinnati Medical CenterCincinnati, OhioUnited StatesNot yet recruiting
Penn State Hershey Medical CenterHershey, PennsylvaniaUnited StatesNot yet recruiting
The University of Texas MD Anderson Cancer CenterHouston, TexasUnited StatesNot yet recruiting
Fred Hutchinson Cancer Research CenterSeattle, WashingtonUnited StatesNot yet recruiting
Medical College of WisconsinMilwaukee, WisconsinUnited StatesNot yet recruiting
Universitair ziekenhuis Antwerpen UZAEdegem, AntwerpBelgiumNot yet recruiting
AZ DeltaRoeselare, West-VlaanderenBelgiumNot yet recruiting
UZ GentGhentBelgiumNot yet recruiting
CHU de LiègeLiègeBelgiumNot yet recruiting
Horizon Health NetworkFredericton, New BrunswickCanadaNot yet recruiting
McGill University Health Research InstituteMontreal, QuebecCanadaNot yet recruiting
FH OstrovaOstrova, CZECzechiaNot yet recruiting
FH Hradec KraloveHradec Králové, Hradec Králové RegionCzechiaNot yet recruiting
Fakultni nemocnice Kralovske VinohradyPragueCzechiaNot yet recruiting
UHKT PrahaPragueCzechiaNot yet recruiting
Department of Medicine, Vejle HospitalVejle, South Region DenmarkDenmarkNot yet recruiting
RigshospitaletCopenhagenDenmarkTerminated
Zealand University HospitalRoskildeDenmarkNot yet recruiting
CHU Rennes - Hopital PontchaillouRennes, ILE ET VilaineFranceNot yet recruiting
CHU de Nantes-Hotel DieuNantes, Loire AtlantiqueFranceNot yet recruiting
CHU Angers - Hôpital Hôtel DieuAngers, Maine Et LoireFranceNot yet recruiting
Centre Hospitalier Départemental Les OudairiesLa Roche-sur-Yon, VendéeFranceNot yet recruiting
Centre Henri BecquerelRouenFranceNot yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort GiessenGiessen, HesseGermanyNot yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet MainzMainz, Rhineland-PalatinateGermanyNot yet recruiting
Fondazione Policlinico Universitario A. gemelli, IRCCSRome, LazioItalyNot yet recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari)Brescia, LombardyItalyNot yet recruiting
Ospedale di Circolo Fondazione MacchiVarese, LombardyItalyNot yet recruiting
Fondazione del Piemonte per l'Oncologia IRCCS CandioloCandiolo, TorinoItalyNot yet recruiting
Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)CataniaItalyNot yet recruiting
Azienda Ospedaliera Universitaria CareggiFlorenceItalyNot yet recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore PoliclinicoMilanItalyNot yet recruiting
Ospedale San RaffaeleMilanItalyNot yet recruiting
MICS Centrum Medyczne TorunTorun, Kuyavian-Pomeranian VoivodeshipPolandNot yet recruiting
Pratia MCM KrakowKrakow, MałopolskaPolandNot yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut BadawczyGliwice, SielesiaPolandNot yet recruiting
Pratia Onkologia KatowiceKatowice, Silesian VoivodeshipPolandNot yet recruiting
Aidport sp z o.o.Skorzewo (Poznan), WielkopolskaPolandNot yet recruiting
Hospital Universitario del VinalopóElche, AlicanteSpainNot yet recruiting
Hospital Clinic de BarcelonaBarcelona, Barcelona/CataloniaSpainNot yet recruiting
Hospital Universitari Germans Trias i PujolBadalona, BarcelonaSpainNot yet recruiting
Hospital Universitario Marques de ValdecillaSantander, CantabriaSpainNot yet recruiting
Vall d'Hebron Institut d'OncologiaBarcelona, CataloniaSpainNot yet recruiting
Pratia ES HLA Hospital Universitario MoncloaMadridSpainNot yet recruiting
Hospital Universitario Fundacion Jimenez DiazMadridSpainNot yet recruiting
Hammersmith HospitalLondon, Greater LondonUnited KingdomNot yet recruiting
Leicester Royal InfirmaryLeicester, LeicestershireUnited KingdomNot yet recruiting
St Bartholomew's HospitalLondonUnited KingdomNot yet recruiting