A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Bristol-Myers Squibb8 个研究点分布在 2 个国家目标入组 5 人开始时间: 2022年9月14日最近更新: 2023年7月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 5
试验地点: 8
主要终点: Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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

•Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
•Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
•Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)

排除标准

•Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study
•Systemic fungal, bacterial, viral, or other infection that is not controlled
•Active autoimmune disease requiring immunosuppressive therapy
•Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen
•Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

BMS-986403 + Fludarabine + Cyclophosphamide

Experimental

干预措施: BMS-986403 (Drug)

BMS-986403 + Fludarabine + Cyclophosphamide

Experimental

干预措施: Fludarabine (Drug)

BMS-986403 + Fludarabine + Cyclophosphamide

Experimental

干预措施: Cyclophosphamide (Drug)

结局指标

主要结局

Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period