Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Occurrence of Dose Limiting Toxicities
研究概览
简要总结
The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide
详细描述
This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.
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
- 未提供
排除标准
- •History or presence of clinically relevant central nervous system (CNS) tumor involvement.
- •Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
- •Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
- •Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
- •Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.
研究组 & 干预措施
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
干预措施: CYAD-211 (Biological)
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
干预措施: Endoxan (Drug)
CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
干预措施: Fludara (Drug)
结局指标
主要结局
Occurrence of Dose Limiting Toxicities
时间窗: Up to 36 days post-infusion.
Occurrence of Dose Limiting Toxicities
次要结局
未报告次要终点