NCT07648264招募中3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- CSL Behring
- 入组人数
- 63
- 试验地点
- 120
- 主要终点
- Number of Serious Bacterial Infections (SBIs) per Participant
研究概览
简要总结
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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is open-label study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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 >
- •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.
研究组 & 干预措施
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.
In the maintenance-only cohort, participants will receive weekly doses of IgPro20 SC infusion for a total treatment duration of 52 weeks.
干预措施: IgPro20 (Biological)
结局指标
主要结局
Number of Serious Bacterial Infections (SBIs) per Participant
时间窗: Up to Month 12
The SBIs includes: bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess.
次要结局
- 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)
- 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)
- 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))
研究者
研究点 (120)
Loading locations...
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