[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642034":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":16,"studyPopulation":16,"armGroups":51,"interventions":58,"overallOfficials":16,"centralContacts":65,"locations":16,"responsibleParty":71,"collaborators":16,"id":73,"slug":16,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":16,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":16,"enrollmentInfo":81,"targetDuration":16,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":100,"whyStopped":16,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":16},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Serious Bacterial Infections (SBIs) per Participant","The SBIs includes: bacteremia \u002F sepsis, bacterial meningitis, osteomyelitis \u002F septic arthritis, bacterial pneumonia, and visceral abscess.","Up to Month 12",[14,17,20,22,24,26,28,30,33,36,39,41],{"measure":15,"description":16,"timeFrame":12},"Number of Infections per Participant",null,{"measure":18,"description":19,"timeFrame":12},"Number of Common Terminology Criteria for Adverse Events (CTCAE) >= Grade 3 Infections per Participant","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.",{"measure":21,"description":16,"timeFrame":12},"Number of Days Hospitalized due to Infections",{"measure":23,"description":16,"timeFrame":12},"Number of Days With Anti-infectives Use",{"measure":25,"description":16,"timeFrame":12},"Number of Infection-related Deaths and Complications",{"measure":27,"description":16,"timeFrame":12},"Number of Infection-related Requirement for Intravenous (IV) Therapy",{"measure":29,"description":16,"timeFrame":12},"Number of Infection-related Requirement for Hospitalization per Participant",{"measure":31,"description":32,"timeFrame":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","In this study, thromboembolic events are treated as AESIs.\n\nThe following 3 narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) queries are used for TEE evaluation:\n\n* Embolic and thrombotic events, arterial\n* Embolic and thrombotic events, venous\n* Embolic and thrombotic events, vessel type unspecified, and mixed arterial and venous.",{"measure":34,"description":16,"timeFrame":35},"Trough Concentrations of Serum IgG","Up to Week 56",{"measure":37,"description":16,"timeFrame":38},"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)",{"measure":40,"description":16,"timeFrame":38},"Maximal Serum Concentration (Cmax) of IgG",{"measure":42,"description":16,"timeFrame":38},"Time to Maximal Serum Concentration (Tmax) of IgG",{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":16,"timePerspective":16,"maskingInfo":48},"NA","SINGLE_GROUP","This is single group open-label study.","TREATMENT",{"masking":49,"maskingDescription":50,"whoMasked":16},"NONE","This is open-label study.",[52],{"label":53,"type":54,"description":55,"interventionNames":56},"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.\n\nIn the maintenance-only cohort, participants will receive weekly doses of IgPro20 SC infusion for a total treatment duration of 52 weeks.",[57],"Biological: IgPro20",[59],{"type":60,"name":53,"description":61,"armGroupLabels":62,"otherNames":63},"BIOLOGICAL","IgPro20 infusion administered SC.",[53],[64],"Immune Globulin Subcutaneous (Human) 20% Liquid",[66],{"name":67,"role":68,"phone":69,"phoneExt":16,"email":70},"Trial Registration Coordinator","CONTACT","+16108784697","clinicaltrials@cslbehring.com",{"type":72,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100642034",false,"NCT07648264","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","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","Inclusion Criteria:\n\n* Participants greater than or equal to (≥) 18 years of age at the time of providing written informed consent.\n* 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.\n* Participants treated with Chimeric antigen receptor T-cell (CAR T-cell) therapy or TCE BsAb and are:\n\n  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\n  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.\n* Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening:\n\n  1. CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria\n  2. MM based on International Myeloma Working Group response criteria\n  3. NHL based on Lugano Classification criteria\n  4. B-ALL based on National Comprehensive Cancer Network guidelines\n* IgG level (excluding paraprotein, if relevant) at Screening:\n\nIf 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 (\\\u003C) 500 milligrams per deciliter (mg\u002FdL) are assigned to the Loading Cohort, participants with IgG ≥ 500 mg\u002FdL are assigned to the Maintenance-only Cohort.\n\n* IgG level (excluding paraprotein, if relevant) at Screening:\n\nIf 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 \\\u003C 500 mg\u002FdL is required for enrollment (participant is assigned to the Loading Cohort)\n\nExclusion Criteria:\n\n* 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.\n* History of thromboembolic event (TEE) within 6 months before Screening.\n* Eastern Cooperative Oncology Group performance status \\> 1.\n* Presence of any systemic active infection at Screening.\n* Participants on any prohibited therapies, including anti-infective treatments.\n* Absolute neutrophil count \\\u003C 1 × 10\\*9\u002FL (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.\n* 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 \u002F 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.","ALL","18 Years",{"count":82,"type":83},63,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","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 (\\\u003C) 1.0.\n\nThis study includes two cohorts:\n\n1. Loading Cohort: Participants with serum immunoglobulin G (IgG) \\\u003C 500 milligrams per deciliter (mg\u002FdL) 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.\n2. Maintenance-only Cohort: Participants with serum IgG greater than or equal to (≥) 500 mg\u002FdL and ongoing IgRT at Screening, who must have received one dose of IgPro20 during the Initial Treatment Period.",[89],"Secondary Immune Deficiency",[91,92,93,94,95,96,97,98,99],"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","NOT_YET_RECRUITING","2026-06-10",{"date":103,"type":104},"2026-06-15","ACTUAL",{"date":106,"type":83},"2026-07-25",{"date":108,"type":83},"2029-02-16",{"name":5,"class":6}]