A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.
详细描述
This is an open-label study. The investigators propose to examine if BMS-986453 in people with newly diagnosed multiple myeloma may help control their disease for a prolonged period of time despite one-time treatment and challenge continuous treatment which is otherwise prescribed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years with no upper age limit
- •NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
- •Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference.
- •ECOG performance status 0-1
- •Adequate organ function
排除标准
- •Known active or history of central nervous system (CNS) involvement of MM.
- •Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis.
- •Prior history of other malignancies
- •Uncontrolled infection
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Single dose BMS-986453
Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion.
A single dose of BMS-986453 administered by IV infusion.
干预措施: BMS-986453 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: Baseline up to 5 years
Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.
次要结局
- Overall Response Rate (ORR)(Baseline up to 5 years)
- Progression Free Survival (PFS)(Baseline up to 5 years)
- MRD negativity(Baseline up to 5 years)
- Overall Survival (OS)(Baseline up to 5 years)
- Pharmacokinetics (PK)(Baseline up to 2 years)
- Complete response rate(Baseline up to 5 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Up to 15 years)
研究者
Susan Bal
Associate Professor
University of Alabama at Birmingham