A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 Chimeric Antigen Receptor T Cells (FIT-CD19-CAR-T Cells) Infusion for Subjects With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse events [Safety and Tolerability]
研究概览
简要总结
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
详细描述
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
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
- •Male or female subjects age ≥18 years
- •Diagnosis of ALL
- •Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
- •Disease burden: Bone marrow with evidence of disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate organ functions
- •Life expectancy ≥12 weeks
排除标准
- •Active central nervous system (CNS) involvement of ALL
- •Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- •Prior anti-CD19 therapy (other than blinatumomab)
- •Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
- •autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
- •History or presence of cardiac or CNS disorders as defined in the protocol
研究组 & 干预措施
ARM011 following lymphodepleting chemotherapy
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
干预措施: ARM011 (Biological)
ARM011 following lymphodepleting chemotherapy
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
干预措施: Fludarabine (Drug)
ARM011 following lymphodepleting chemotherapy
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Incidence of adverse events [Safety and Tolerability]
时间窗: Up to 24 months after ARM011 infusion
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
次要结局
- Evaluate cellular kinetics and persistence of ARM011(Up to 24 months after ARM011 infusion)
- Evaluate preliminary anti-tumor activity of ARM011(Up to 24 months after ARM011 infusion)
- Evaluate host immunogenicity to ARM011(Up to 24 months after ARM011 infusion)
- Evaluate the feasibility of administration of ARM011(24 months)