2024-512903-38-00进行中（未招募）2 期
An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 34
- 主要终点
- Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion.
研究概览
简要总结
- To evaluate the safety of AUTO1.
- To evaluate the clinical efficacy of AUTO1.
详细描述
This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR).
Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (± 2 days).
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Relapsed or refractory CD19-positive B-ALL
- •Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed two lines of any tyrosine kinase inhibitor (TKI) or one line of second-generation TKI, or if TKI therapy is contraindicated.
- •In patients treated with blinatumomab, CD19 expression should be confirmed after blinatumomab therapy has been stopped.
- •Adequate renal, hepatic, pulmonary, and cardiac function
排除标准
- •Diagnosis of Burkitt’s leukaemia/lymphoma according to World Health Organisation (WHO) classification or chronic myelogenous leukaemia lymphoid in blast crisis.
- •History or presence of clinically relevant CNS pathology
- •Presence of CNS 3 disease or CNS 2 disease with neurological changes
- •Active or latent Hepatitis B or active Hepatitis C.
研究组 & 干预措施
AUTO1
Experimental
干预措施: AUTO1 (Biological)
结局指标
主要结局
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion.
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion.
Cohort IIA: Overall complete remission rate (ORR) defined as proportion of patients achieving CR or CRi as assessed by an Independent Response Review Committee (IRRC). Cohort IIB: Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<10-4 leukaemic cells)
Cohort IIA: Overall complete remission rate (ORR) defined as proportion of patients achieving CR or CRi as assessed by an Independent Response Review Committee (IRRC). Cohort IIB: Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<10-4 leukaemic cells)
次要结局
- Complete Remission Rate (CRR). CRR within 3 months post AUTO1 infusion. Proportion of patients achieving MRD-negative remission by central ClonoSEQ NGS testing (<10-4 leukaemic cells), PCR and/or flow cytometry. Duration of remission (DOR). Duration of complete remission (DOCR). Event free survival (EFS). Progression free survival (PFS). Overall survival (OS). ORR [CR+CRi] as assessed by the Investigator.
- Frequency and severity of AEs and SAEs. Incidence and duration of severe hypogammaglobulinaemia.
- Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered.
- Detection of CAR T cells measured by PCR in the peripheral blood and BM following AUTO1 infusion.
- Depletion of circulating B cells assessed by flow cytometry in the peripheral blood.
研究者
Wolfram Brugger
Scientific
Autolus Limited
研究点 (34)
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