NCT06292780招募中1 期
A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 39
- 主要终点
- Incidence of dose-limiting toxicity (DLTs)
研究概览
简要总结
This study is researching an experimental drug called linvoseltamab ("study drug").
This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.
The study consists of 2 phases (Phase 1 and Phase 2):
- In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.
- In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.
The study is looking at several other research questions, including:
- How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long
- How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long
- What the right dosing regimen is for linvoseltamab
- What side effects may happen from taking linvoseltamab
- How much linvoseltamab is in the blood at different times
- Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed diagnosis of AL amyloidosis, as described in the protocol
- •Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol
- •Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator
- •N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening
- •Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol
- •Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening
排除标准
- •History of other non-AL amyloidosis
- •Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening
- •Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening
- •Myocardial infarction within the past 6 months prior to the first screening visit
- •Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Phase 1: Cohort 1: Low Dose
Experimental
Dose Escalation: Non-Randomized
干预措施: Linvoseltamab (Drug)
Phase 2: Low Dose
Experimental
Dose Expansion: Participants will be randomized in a 1:1 ratio
干预措施: Linvoseltamab (Drug)
Phase 2: High Dose
Experimental
Dose Expansion: Participants will be randomized in a 1:1 ratio
干预措施: Linvoseltamab (Drug)
Phase 1: Cohort 2: High Dose
Experimental
Dose Escalation: Non-Randomized
干预措施: Linvoseltamab (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLTs)
时间窗: Up to 28 Days
Phase 1
Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
时间窗: Up to 3 years
Phase 2
次要结局
- Severity of TEAEs(Up to 39 months)
- Time from treatment initiation to kidney deterioration as determined by the IRC(Up to 7 years)
- Time to initial hematologic response(Up to 3 years)
- Hematologic progression-free survival (PFS)(Up to 7 years)
- Incidence of serious adverse events (SAEs)(Up to 39 months)
- Severity of AESIs(Up to 39 months)
- Time from treatment initiation to hematologic disease progression as determined by the IRC(Up to 7 years)
- Time from treatment initiation to death as determined by the IRC(Up to 7 years)
- Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC(Up to 7 years)
- Time to first renal response in participants with renal involvement at baseline(Up to 7 years)
- Time to best hematologic response(Up to 3 years)
- Incidence of treatment-emergent adverse events (TEAEs)(Up to 39 months)
- Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2(Up to 39 months)
- Achievement of renal response in participants with renal involvement at baseline, as determined by IRC(Up to 7 years)
- Linvoseltamab concentration in serum over time(Up to 39 months)
- Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time(Up to 39 months)
- Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC(Up to 3 years)
- Achievement of overall hematologic response (PR or better), as determined by the IRC(Up to 3 years)
- Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC(Up to 7 years)
- Severity of SAEs(Up to 39 months)
- Incidence of TEAEs in dose regimen 1 vs 2(Up to 39 months)
- Severity of TEAEs in dose regimen 1 vs 2(Up to 39 months)
- Severity of SAEs in dose regimen 1 vs 2(Up to 39 months)
- Incidence of AESIs in dose regimen 1 vs 2(Up to 39 months)
- Titers of ADAs to linvoseltamab over time(Up to 39 months)
- Achievement of hematologic CR, as determined by the IRC(Up to 3 years)
- Incidence of death(Up to 7 years)
- Incidence of adverse events of special interest (AESIs)(Up to 39 months)
- Incidence of SAEs in dose regimen 1 vs 2(Up to 39 months)
- Severity of AESIs in dose regimen 1 vs 2(Up to 39 months)
- Time from treatment initiation to cardiac deterioration, as determined by the IRC(Up to 7 years)
- Time from initiation of treatment to date of death from any cause(Up to 7 years)
- Time to first cardiac response in participants with cardiac involvement at baseline(Up to 7 years)
研究者
研究点 (39)
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