A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 9
- 主要终点
- Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
研究概览
简要总结
The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
- •Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (>=) 1 complete cycle of the therapy
- •Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening
排除标准
- •Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
- •Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (<)12 weeks before apheresis/first dose of study treatment
- •Receive live, attenuated vaccine within 4 weeks of enrollment
- •Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- •Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
研究组 & 干预措施
Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy
Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.
干预措施: Talquetamab (Drug)
Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) Therapy
Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.
干预措施: Cilta-cel (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
时间窗: Up to 3 years and 5 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
次要结局
- Percentage of Participants With Overall Response (OR)(Up to 3 years and 5 months)
- Percentage of Participants with Very Good Partial Response (VGPR) or Better(Up to 3 years and 5 months)
- Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)(Up to 3 years and 5 months)
- Duration of Response (DOR)(Up to 3 years and 5 months)
- Time to Response (TTR)(Upto 3 years and 5 months)
- Progression Free Survival (PFS)(Up to 3 years and 5 months)
- Overall Survival(Up to 3 years and 5 months)
- Percentage of Participants with Minimal Residual Disease (MRD) Negativity(Up to 3 years and 5 months)
- Percentage of Participants with Sustained MRD-Negativity(Up to 3 years and 5 months)