2023-507809-34-00招募中2 期
A Phase 1/2 Study of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis
Regeneron Pharmaceuticals Inc.6 个研究点 分布在 2 个国家目标入组 23 人开始时间: 2024年6月3日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 6
- 主要终点
- Phase 1: Incidence of dose-limiting toxicity (DLTs)
研究概览
简要总结
-Phase 1: To assess the safety, tolerability and to determine the recommended phase 2 dose regimens (RP2DRs) of linvoseltamab in participants with relapsed or refractory AL amyloidosis. -Phase 2: To evaluate the effect of linvoseltamab on hematologic complete response in participants with relapsed or refractory AL amyloidosis
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •NOTE: Other protocol defined inclusion criteria apply
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 exclusion criteria apply
结局指标
主要结局
Phase 1: Incidence of dose-limiting toxicity (DLTs)
Phase 1: Incidence of dose-limiting toxicity (DLTs)
Phase 2: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
Phase 2: Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
次要结局
- Achievement of hematologic CR, as determined by the IRC - Phase 1
- Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC
- Achievement of overall hematologic response (PR or better), as determined by the IRC
- Time to initial hematologic response
- Time to best hematologic response
- Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC
- Hematologic progression-free survival (PFS)
- Incidence of death
- Incidence of treatment-emergent adverse events (TEAEs)
- Severity of TEAEs
- Incidence of serious adverse events (SAEs)
- Severity of SAEs
- Incidence of adverse events of special interest (AESIs)
- Severity of AESIs
- Achievement of overall hematologic response (PR or better), as determined by the IRC in full dose regimen 1 vs 2 - Phase 2
- Incidence of TEAEs in full dose regimen 1 vs 2 - Phase 2
- Severity of TEAEs in full dose regimen 1 vs 2 - Phase 2
- Incidence of SAEs in full dose regimen 1 vs 2 - Phase 2
- Severity of SAEs in full dose regimen 1 vs 2 - Phase 2
- Incidence of AESIs in full dose regimen 1 vs 2 - Phase 2
- Severity of AESIs in full dose regimen 1 vs 2 - Phase 2
- Time from treatment initiation to hematologic disease progression as determined by the IRC
- Time from treatment initiation to cardiac deterioration, as determined by the IRC
- Time from treatment initiation to kidney deterioration as determined by the IRC
- Time from treatment initiation to death as determined by the IRC
- Time from initiation of treatment to date of death from any cause
- Achievement of renal response in participants with renal involvement at baseline, as determined by IRC
- Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC
- Time to first renal response in participants with renal involvement at baseline
- Time to first cardiac response in participants with cardiac involvement at baseline
- Linvoseltamab concentration in serum over time
- Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time
- Titers of ADAs to linvoseltamab over time
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (6)
Loading locations...
相似试验
招募中
2 期
A Window of Opportunity Trial To Learn If Linvoseltamab Is Safe And Well Tolerated, And How Well It Works In Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received TreatmentMultiple Myeloma2022-500800-24-00Regeneron Pharmaceuticals Inc.76
招募中
3 期
Locally Advanced or Metastatic Hepatocellular Carcinoma: Dose Optimization, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab in Subjects Who Have Not Previously Received Systemic Treatment – LIVIGNO-22023-504600-28-00AbbVie Deutschland GmbH & Co. KG40
招募中
2 期
Phase II study: efficacy and safety of tislelizumab in patients with de novo Hodgkin lymphoma unsuitable for standard chemotherapyHodgkin lymphoma2022-503090-11-00Fondazione Italiana Linfomi Onlus25
已完成
2 期
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
尚未招募
1 期
Safety and Efficacy of the JAK1 Inhibitor Combined With Intensive Immunosuppressive Therapy in Severe Aplastic AnemiaSevere Aplastic AnemiaNCT07297550Institute of Hematology & Blood Diseases Hospital, China42