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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат IgPro20
  IgPro20 infusion administered SC.

Первичные конечные точки

• Number of Serious Bacterial Infections (SBIs) per Participant [Срок оценки: Up to Month 12]

Вторичные конечные точки (12)

• Number of Infections per Participant [Срок оценки: Up to Month 12]
• Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant [Срок оценки: Up to Month 12]
• Number of Days Hospitalized due to Infections [Срок оценки: Up to Month 12]
• Number of Days With Anti-infectives Use [Срок оценки: Up to Month 12]
• Number of Infection-related Deaths and Complications [Срок оценки: Up to Month 12]
• Number of Infection-related Requirement for Intravenous (IV) Therapy [Срок оценки: Up to Month 12]
• Number of Infection-related Requirement for Hospitalization per Participant [Срок оценки: 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 [Срок оценки: Up to Month 12]
• Trough Concentrations of Serum IgG [Срок оценки: Up to Week 56]
• Area Under the Serum Concentration Time Curve (AUC) for IgG From Timepoint Zero to tau (AUC[0-t]) [Срок оценки: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)]
• Maximal Serum Concentration (Cmax) of IgG [Срок оценки: 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 [Срок оценки: Before IgPro20 dosing at Week 52 and up to Week 54 (after the last dose of IgPro20)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 17 центров

• UC Irvine — Orange
• CBCI, Colorado Blood Cancer Institute — Denver
• SSAK Partners — Coral Springs
• Mayo Clinic - Jacksonville — Jacksonville
• Indiana University Health Arnett, Inc. — Lafayette
• Johns Hopkins Asthma & Allergy Center — Baltimore
• American Oncology Partners, PA dba The Center for Cancer and Blood Disorders — Bethesda
• Hackensack Meridian Health — Hackensack
• … и ещё 9 центров

Италия · 8 центров

• Fondazione Policlinico Universitario A. gemelli, IRCCS — Rome
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Montichiari — Brescia
• Ospedale di Circolo Fondazione Macchi — Varese
• Fondazione del Piemonte per l'Oncologia IRCCS Candiolo — Candiolo
• Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. — Catania
• Azienda Ospedaliera Universitaria Careggi — Florence
• Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan
• Ospedale San Raffaele — Milan

Испания · 7 центров

• Hospital Universitario del Vinalopó — Elche
• Hospital Clinic de Barcelona — Barcelona
• Hospital Universitari Germans Trias i Pujol — Badalona
• Hospital Universitario Marques de Valdecilla — Santander
• Vall d'Hebron Institut d'Oncologia — Barcelona
• Pratia ES HLA Hospital Universitario Moncloa — Madrid
• Hospital Universitario Fundacion Jimenez Diaz — Madrid

Франция · 5 центров

• CHU Rennes - Hopital Pontchaillou — Rennes
• CHU de Nantes-Hotel Dieu — Nantes
• CHU Angers - Hôpital Hôtel Dieu — Angers
• Centre Hospitalier Départemental Les Oudairies — La Roche-sur-Yon
• Centre Henri Becquerel — Rouen

Польша · 5 центров

• MICS Centrum Medyczne Torun — Torun
• Pratia MCM Krakow — Krakow
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy — Gliwice
• Pratia Onkologia Katowice — Katowice
• Aidport sp z o.o. — Skorzewo (Poznan)

Бельгия · 4 центра

• Universitair ziekenhuis Antwerpen UZA — Edegem
• AZ Delta — Roeselare
• UZ Gent — Ghent
• CHU de Liège — Liège

Чехия · 4 центра

• FH Ostrova — Ostrova
• FH Hradec Kralove — Hradec Králové
• Fakultni nemocnice Kralovske Vinohrady — Prague
• UHKT Praha — Prague

Дания · 3 центра

• Department of Medicine, Vejle Hospital — Vejle
• Rigshospitalet — Copenhagen
• Zealand University Hospital — Roskilde

Великобритания · 3 центра

• Hammersmith Hospital — London
• Leicester Royal Infirmary — Leicester
• St Bartholomew's Hospital — London

Канада · 2 центра

• Horizon Health Network — Fredericton
• McGill University Health Research Institute — Montreal

Германия · 2 центра

• Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen — Giessen
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz

Идентификаторы

NCT: NCT07648264 · IgPro20_3013 · 2026-525626-38-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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