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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

2026年9月4日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

63

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
生物：IgPro20
IgPro20 infusion administered SC.
其他名称：
  • Immune Globulin Subcutaneous (Human) 20% Liquid

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Serious Bacterial Infections (SBIs) per Participant
大体时间：Up to Month 12
The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
Up to Month 12

次要结果测量

结果测量
措施说明
大体时间
Number of Infections per Participant
大体时间：Up to Month 12
Up to Month 12
Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant
大体时间：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
大体时间：Up to Month 12
Up to Month 12
Number of Days With Anti-infectives Use
大体时间：Up to Month 12
Up to Month 12
Number of Infection-related Deaths and Complications
大体时间：Up to Month 12
Up to Month 12
Number of Infection-related Requirement for Intravenous (IV) Therapy
大体时间：Up to Month 12
Up to Month 12
Number of Infection-related Requirement for Hospitalization per Participant
大体时间：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
大体时间：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
大体时间：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])
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

CSL Behring

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月11日

初级完成 (估计的)

2029年3月13日

研究完成 (估计的)

2029年3月13日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IgPro20_3013
  • 2026-525626-38-00 (注册表标识符：EU CT Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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