A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects With Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 183
- 试验地点
- 34
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
详细描述
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
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
- •History of multiple myeloma with relapsed and refractory disease
- •Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •Must have measurable disease as determined by the central laboratory
排除标准
- •Symptomatic central nervous system involvement of multiple myeloma
- •Prior autologous stem cell transplant ≤ 3 months prior
- •Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
- •History of concurrent second cancers requiring active, ongoing systemic treatment
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Administration of CC-93269
干预措施: CC-93269 (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to approximately 63 months
Number of participants with Adverse Events
Dose Limiting Toxicity (DLT)
时间窗: Up to 60 months
Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
Non-Tolerated Dose (NTD)
时间窗: Up to 60 months
Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
Maximum Tolerated Dose (MTD)
时间窗: Up to 60 months
Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
次要结局
- Pharmacokinetics - Vss(Up to 60 months)
- Pharmacokinetics - accumulation index of alnuctamab(Up to 60 months)
- Presence and frequency of anti-drug antibodies (ADA)(Up to 60 months)
- Overall Response Rate (ORR)(Up to 60 months)
- Time to Response(Up to 60 months)
- Duration of Response(Up to 60 months)
- Progression Free Survival(Up to 60 months)
- Overall Survival(Up to 60 months)
- Pharmacokinetics - Cmax(Up to 60 months)
- Pharmacokinetics - Cmin(Up to 60 months)
- Pharmacokinetics - AUC(Up to 60 months)
- Pharmacokinetics - tmax(Up to 60 months)
- Pharmacokinetics - t1/2(Up to 60 months)
- Pharmacokinetics - CL(Up to 60 months)