A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 38
- 主要终点
- Primary outcome measures number of patients with dose-limiting toxicities (Part A).
研究概览
简要总结
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.
详细描述
This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age greater than or equal to 18 at the time of enrollment
- •Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Adequate hematologic, renal, liver, cardiac and pulmonary organ function
排除标准
- •Prior therapy with an anti-CD19 targeting agent
- •Active or chronic graft versus host disease requiring therapy
- •Prior allogeneic stem cell transplantation
- •Central nervous system (CNS) lymphoma, prior CNS malignancy
- •Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
- •Primary immunodeficiency
- •Current or expected need for systemic corticosteroid therapy
- •Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
- •Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
- •Unwillingness to follow extended safety monitoring
研究组 & 干预措施
Dose Escalation of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: CB-010 (Genetic)
Dose Escalation of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: Cyclophosphamide (Drug)
Dose Escalation of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: Fludarabine (Drug)
Expansion of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: CB-010 (Genetic)
Expansion of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: Cyclophosphamide (Drug)
Expansion of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
时间窗: 28 days following CB-010 infusion
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Primary outcome evaluates tumor response (Part B)
时间窗: Up to 12 months
The primary endpoint is objective response rate.
次要结局
未报告次要终点