A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Juno Therapeutics, a Subsidiary of Celgene10 个研究点分布在 1 个国家目标入组 130 人开始时间: 2021年2月24日最近更新: 2026年2月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 130
试验地点: 10
主要终点: Number of participants with Adverse Events (AEs)

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 CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).

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

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

•Age ≥ 18 years
•Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months.
•Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including:
•Autologous HSCT, unless the subject was ineligible
•A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination
•Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy.
•Measurable disease
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Adequate organ function

排除标准

•Known active or history of central nervous system (CNS) involvement of MM
•Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
•Active autoimmune disease requiring immunosuppressive therapy
•History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis
•Other protocol-defined inclusion/exclusion criteria apply.

研究组 & 干预措施

Administration of CC-95266

Experimental

干预措施: CC-95266 (Drug)

Administration of CC-95266

Experimental

干预措施: Fludarabine (Drug)

Administration of CC-95266

Experimental

干预措施: Cyclophosphamide (Drug)

Administration of CC-95266

Experimental

干预措施: Bendamustine (Drug)