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临床试验/CTIS2024-512903-38-00
CTIS2024-512903-38-00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.

Autolus Limited0 个研究点目标入组 153 人开始时间: 2024年6月11日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
153

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Age 18 years or older., Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1., 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.

研究者

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