A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.
研究概览
简要总结
This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
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
- 10 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis that qualifies them for a DUCBT
- •Absence of recent active mold infection
- •Adequate organ function
- •Availability of eligible donor material
排除标准
- •Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
- •Human immunodeficiency virus (HIV) infection
- •Active infection
- •Extensive prior chemotherapy
- •Prior myeloablative allotransplantation or autologous transplant.
结局指标
主要结局
Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.
时间窗: 32 days
The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.
次要结局
- Incidence of Neutrophil Recovery Within 42 Days(42 days)
- Incidence of Platelet Recovery Within Six Months(6 months)
- Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)(Day 100)
- Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year(Day 100 and Month 12)
- Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year(Day 100 and Monnth 12)
- Incidence of Relapse Within One Year(Month 12)
- Overall Survival (OS) Within One Year(Month 12)
- Disease Free Survival (DFS) Within One Year(Month 12)