A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 18
- 主要终点
- Safety Lead-In
研究概览
简要总结
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).
详细描述
This study is in patients aged ≥18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML.
Potential patients for the study may be screened/enrolled:
• Prior to their first allogeneic HSCT.
or
• Patients experiencing their first relapse post-allogeneic transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
研究组 & 干预措施
MT-401 following HSCT
Treatment with MT-401 at 90 days following HSCT
干预措施: MT-401 (Drug)
MT-401 following relapse
Treatment with MT-401 following relapse after first HSCT
干预措施: MT-401 (Drug)
结局指标
主要结局
Safety Lead-In
时间窗: Baseline through Cycle 1 (28 Days)
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Phase 2 Active Disease Group
时间窗: Up to 24 months
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
Phase 2 Adjuvant Group
时间窗: Up to 24 months after the first participant is randomized
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
次要结局
未报告次要终点