Phase I Study to Evaluate the Safety and Efficacy of NK Cell Therapy in Acute Myeloid Leukemia (AML).
概览
- 阶段
- 1 期
- 干预措施
- CD33/CLL1 dual CAR-NK cell
- 疾病 / 适应症
- AML, Adult
- 发起方
- Institute of Hematology & Blood Diseases Hospital, China
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of iPSC NK cells in patients with relapsed/refractory AML or AML Minimal Residual Disease (MRD).
研究者
入排标准
入选标准
- •Provision of signed and dated informed consent form (ICF).
- •≥18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.
- •Diagnosis of r/r AML (Cohort 1 and 2) or AML MRD (Cohort 3).
- •Cohort 1: Both CLL1 and CD33 expression are positive in AML blasts; Cohort 2: The expression of CD33 in AML blast is positive.
- •Adequate organ and marrow function, as defined below:
- •Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min;
- •Total bilirubin (TBIL) ≤ 2 x the ULN;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;
- •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN;
排除标准
- •Allergic to drug used in this study.
- •Subjects received any antitumor therapy as follows, prior to first NK infusion:
- •Systemic steroid therapy within 3 days (except physiological replacement therapy);
- •Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less;
- •Radiotherapy within 4 weeks;
- •Donor lymphocyte infusion within 6 weeks;
- •Intrathecal treatment within 1 week;
- •CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;
- •History of allogeneic stem cell transplantation.
- •Received the vaccine within 4 weeks prior to the first infusion and/or expected to require vaccination from the study period to 12 weeks after the last infusion.
研究组 & 干预措施
CD33/CLL1 dual CAR-NK cell
CLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: CD33/CLL1 dual CAR-NK cell
CD33/CLL1 dual CAR-NK cell
CLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Cyclophosphamid
CD33/CLL1 dual CAR-NK cell
CLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Fludarabine
CD33/CLL1 dual CAR-NK cell
CLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Cytarabine
CD33 CAR-NK cell
CD33 CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Cyclophosphamid
CD33 CAR-NK cell
CD33 CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Fludarabine
CD33 CAR-NK cell
CD33 CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: Cytarabine
CD33 CAR-NK cell
CD33 CAR-NK cell therapy in Adult subjects with r/r AML
干预措施: CD33 CAR-NK cell
super NK cell
super NK cell therapy in Adult subjects with AML MRD
干预措施: Cyclophosphamid
super NK cell
super NK cell therapy in Adult subjects with AML MRD
干预措施: Fludarabine
super NK cell
super NK cell therapy in Adult subjects with AML MRD
干预措施: Cytarabine
super NK cell
super NK cell therapy in Adult subjects with AML MRD
干预措施: super NK cell
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 28 Days from first dose of iPSC NK cell infusion
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
时间窗: 28 Days from first dose of iPSC NK cell infusion
次要结局
- Overall Response Rate(ORR)(Up to approximately 2 years after last dose of iPSC NK cell infusion)
- MRD negative rate(28 Days from first dose of iPSC NK cell infusion)
- Event-free survival(Up to approximately 2 years after last dose of iPSC NK cell infusion])
- Relapse-free survival(Up to approximately 2 years after last dose of iPSC NK cell infusion)
- Overall survival (OS)(Up to approximately 2 years after last dose of iPSC NK cell infusion)
- Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood(Up to approximately 2 years after last dose of iPSC NK cell infusion)