NCT06297226招募中2 期
A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company101 个研究点 分布在 4 个国家目标入组 230 人开始时间: 2024年3月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 101
- 主要终点
- Cohort 1: Best overall response (BOR) of partial response (PR) or better
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
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
- •Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
- •Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
- •Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
- •Participants must have measurable disease during screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Active or history of central nervous system involvement with MM.
- •Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
- •Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arlocabtagene Autoleucel Cohort 1
Experimental
干预措施: Arlocabtagene Autoleucel (Biological)
Arlocabtagene Autoleucel Cohort 2
Experimental
干预措施: Arlocabtagene Autoleucel (Biological)
结局指标
主要结局
Cohort 1: Best overall response (BOR) of partial response (PR) or better
时间窗: Up to approximately 5 years
The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)
次要结局
- Area under the concentration-time curve (AUC)(Up to approximately 5 years)
- Time of maximum observed plasma concentration (Tmax)(Up to approximately 5 years)
- Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales(Up to approximately 5 years)
- Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up(Up to approximately 5 years)
- Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)(Up to approximately 5 years)
- BOR of partial response (PR) or better(Up to approximately 5 years)
- Minimal residual disease (MRD) negative status(Up to approximately 5 years)
- Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)(Up to approximately 5 years)
- Duration of response (DOR) assessed by an IRC(Up to approximately 5 years)
- Progression-free survival (PFS)(Up to approximately 5 years)
- Overall survival (OS)(Up to approximately 5 years)
- Overall response rate (ORR) assessed by an Investigator(Up to approximately 5 years)
- Complete response rate (CRR) assessed by an Investigator(Up to approximately 5 years)
- Time to response (TTR) assessed by an Investigator(Up to approximately 5 years)
- Duration of response (DOR) assessed by an Investigator(Up to approximately 5 years)
- Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator(Up to approximately 5 years)
- Maximum observed plasma concentration (Cmax)(Up to approximately 5 years)
- Best overall response (BOR) of complete response (CR) including stringent complete response (sCR)(Up to approximately 5 years)
- BOR of partial response (PR) or better(Up to approximately 5 years)
- Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC)(Up to approximately 5 years)
- Minimal residual disease (MRD) negative status(Up to approximately 5 years)
- Duration of response (DOR) assessed by an IRC(Up to approximately 5 years)
- Progression-free survival (PFS)(Up to approximately 5 years)
- Overall survival (OS)(Up to approximately 5 years)
- Overall response rate (ORR) assessed by an Investigator(Up to approximately 5 years)
- Complete response rate (CRR) assessed by an Investigator(Up to approximately 5 years)
- Duration of response (DOR) assessed by an Investigator(Up to approximately 5 years)
- Time to response (TTR) assessed by an Investigator(Up to approximately 5 years)
- Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator(Up to approximately 5 years)
- Maximum observed plasma concentration (Cmax)(Up to approximately 5 years)
- Area under the concentration-time curve (AUC)(Up to approximately 5 years)
- Time of maximum observed plasma concentration (Tmax)(Up to approximately 5 years)
- Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales(Up to approximately 5 years)
- Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up(Up to approximately 5 years)
研究者
研究点 (101)
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相关资讯
Arlo-Cel and Antio-Cel Show Promise in Relapsed/Refractory Multiple Myeloma- Arlocabtagene autoleucel (arlo-cel) demonstrated a 91% overall response rate in heavily pretreated multiple myeloma patients, regardless of high-risk cytogenetics or prior BCMA-directed therapy.
- Antio-cel showed a 95% overall response rate and a 62% complete/stringent complete response rate in relapsed/refractory multiple myeloma, with 92% of patients achieving minimal residual disease negativity.
- Both arlo-cel and antio-cel exhibit manageable safety profiles, with common adverse events being hematological and cytokine release syndrome, respectively, and no unexpected neurotoxicities observed with antio-cel.last yearBMS-986393 CAR-T Shows Promise in Relapsed/Refractory Multiple Myeloma- BMS-986393, a GPRC5D-targeted CAR T-cell therapy, demonstrated a 96% objective response rate in patients with relapsed/refractory multiple myeloma after 1-3 prior lines of therapy.
- The phase 1 trial showed a stringent complete response rate of 37.5% and a very good partial response rate of 33.3% at a median follow-up of 5.3 months.
- The CAR-T therapy exhibited a manageable safety profile, with cytokine release syndrome being mostly low grade and neurotoxicity occurring in a small percentage of patients.
- Ongoing studies are evaluating BMS-986393 as a monotherapy and in combination with other agents for relapsed/refractory multiple myeloma, addressing an unmet need.last year