A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- (Part B) Overall Response Rate (ORR)
研究概览
简要总结
CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory). Participants must have received at least 1 but not more than 3 prior lines of treatment for AML .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Documented diagnosis of AML with either refractory or relapsed disease,
- •Non-proliferative disease
- •No more than 3 prior lines of therapy (induction, consolidation with or without allogeneic stem cell transplant, and maintenance are considered 1 line of therapy)
- •No available therapy with reasonable survival benefit
- •Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
- •Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
- •Women of child-bearing potential and men with a female partner who has child-bearing potential must agree to use acceptable, effective methods of birth control.
排除标准
- •Acute promyelocytic leukemia
- •Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT
- •Prior treatment with CAR-T cell therapy
- •Allogeneic stem cell transplant within 100 days before lymphodepletion
- •Active graft-vs-host disease requiring therapy
- •Known active or prior history of central nervous system involvement
- •Seropositive for or history of human immunodeficiency virus (HIV)
- •Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion
- •Active hepatitis B or C infection
- •Primary immunodeficiency or autoimmune disease
- •Known life-threatening allergies, hypersensitivity, or intolerance to CB-012 or its excipients
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Dose Escalation of CB-012
Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified.
干预措施: CB-012 (Drug)
Dose Expansion of CB-012
Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D.
干预措施: CB-012 (Drug)
结局指标
主要结局
(Part B) Overall Response Rate (ORR)
时间窗: 12 months
The ORR will be evaluated by European Leukemia Net (ELN) criteria
(Part A) Number of patients with dose limiting toxicities (DLT)
时间窗: 28 days
Number of patients with DLTs during the 28 days following the first administration of CB-012.
次要结局
未报告次要终点