EUCTR2019-001937-16-GB进行中（未招募）1 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.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 18 or older.
- •2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- •3. Relapsed or refractory B-precursor ALL
- •4. Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed 2 lines of any tyrosine kinase inhibitor (TKI) or 1 line of second-generation TKI, or if TKI therapy is contraindicated.
- •5. Documentation of CD19 expression on leukaemic blasts
- •6. Phase Ib:
- •Primary Cohort IA: Presence of =5% blasts in BM at screening.
- •Exploratory Cohort IB: MRD-positive defined as =10^-4 and <5% blasts in the BM at screening.
- •Primary Cohort IIA: Presence of =5% blasts in BM at screening.
- •Exploratory Cohort IIB: MRD-positive defined as =10^-4 and <5% blasts in the BM at screening or isolated EM disease with the exception of CNS disease at screening.
- •7. Adequate renal, hepatic, pulmonary, and cardiac function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Phase Ib (Cohort IA and Cohort IB) and Phase II Cohort IIA only: ALL with isolated EM disease.
- •2. Diagnosis of Burkitt's leukaemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukaemia lymphoid blast crisis.
- •3. History or presence of clinically relevant CNS pathology.
- •4. Presence of CNS-3 disease or CNS-2 disease with neurological changes.
- •5. Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
- •6. Active or latent Hepatitis B virus or active Hepatitis C virus
- •7. Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
- •9. Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
研究者
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