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临床试验/EUCTR2016-004680-39-GB
EUCTR2016-004680-39-GB进行中（未招募）1 期

A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia. - AMELIA

Autolus Limited0 个研究点目标入组 70 人开始时间: 2017年3月3日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

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

  • •Paediatric and young adult patients
  • •1. Male or female paediatric and young adults (age 1-24 years) with high risk relapsed or refractory B-cell Acute Lymphoblastic Leukaemia
  • •2. Documented CD19 and or CD22 expression
  • •3. Detectable disease in the bone marrow (Phase I) at enrolment
  • •4. Absolute Lymphocyte Count =0.5 x 10e9/l at enrolment
  • •5. Adequate renal, hepatic, pulmonary & cardiac function including:
  • •- Left ventricular shortening fraction =28% confirmed by ECHO, or left ventricular ejection fraction (LVEF) =45% confirmed by ECHO.
  • •- Baseline oxygen saturation >92% on room air.
  • •6. Karnofsky (age 10-24 years) or Lansky (age < 10 years) score = 50%
  • •7. Willing and able to give written informed consent/assent.
  • •Phase II Only:
  • •8. Primary refractory disease defined as MRD >5% blasts in the BM by flow cytometry or molecular assay following frontline induction therapy OR
  • •- Patients with Philadelphia chromosome-positive ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated OR
  • •- Isolated CNS relapse but with =CNS grade 2 disease at time of enrolment
  • •Adult patients
  • •1. Age 25 or older
  • •2. Eastern cooperative oncology group performance status of 0 or 1
  • •3. Relapsed or refractory B-precursor ALL defined as one of the following:
  • •4. Patients with Philadelphia chromosome positive ALL are eligible if they are intolerant to or have failed 2 lines of TKI therapy, or if TKI therapy is contraindicated
  • •5. Documentation of CD19 and/ or CD22 expression on leukaemic blasts in the BM, peripheral blood, or CSF by flow cytometry within 3 months of screening
  • •6. For females of childbearing potential, a negative serum or urine pregnancy test
  • •7. For females who are not postmenopausal or who are not surgically sterile & males, two methods of contraception should be used
  • •8. Absolute lymphocyte count =0.5 x 109/L at enrolment
  • •9. Adequate renal, hepatic, pulmonary, and cardiac function defined as:
  • •- LVEF =45% confirmed by ECHO or MUGA.
  • •- Baseline oxygen saturation >92% on room air
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 100
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 40
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 4

排除标准

  • •Paediatric and young adult patients
  • •1. Isolated extramedullary disease relapse (in Phase II, patients with isolated CNS relapse post-SCT or pre-SCT if high risk, aged 16-24 years on therapy relapse or = 2nd relapse with =CNS grade 2 disease at time of enrolment)
  • •2. Active CNS involvement of ALL, defined by CNS Grade 3 per National Comprehensive Cancer Network guidelines. Patients developing CNS Grade 3 disease at any time after enrolment will also be excluded
  • •3. Active infectious bacterial or viral disease requiring treatment.
  • •4. Females who are pregnant or lactating.
  • •5. Females of child-bearing potential and post-pubertal males who unwilling to use highly effective methods of contraception during the treatment period and 1 year after AUTO3 infusion.
  • •6. Pre-existing significant neurological disorder
  • •7. Stem Cell Transplant patients only: active significant (overall Grade =II, Seattle criteria) acute graft versus host disease (GVHD) or moderate/severe chronic GVHD (National Institutes of Health [NIH] consensus criteria) requiring systemic steroids or other immunosuppressant within 4 weeks of enrolment
  • •8. The following treatments are excluded:
  • •- Steroids: Therapeutic doses must be stopped >72 hours prior to AUTO3 infusion and leukapheresis.
  • •- Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed >6 weeks prior to AUTO3 infusion
  • •- GVHD therapies: Any drug used for GVHD must be stopped >4 weeks prior to AUTO3 infusion
  • •- Chemotherapy: Stopped 1 week prior to leukapheresis and 2 days prior to starting pre-conditioning chemotherapy
  • •- Intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (eg Ara-C) within 2 weeks prior to starting pre conditioning chemotherapy.
  • •- Live vaccine = 4 weeks prior to enrolment.
  • •9. Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.
  • •Adult patients
  • •1. Isolated extramedullary disease
  • •2. Diagnosis of Burkitt's leukaemia/lymphoma or chronic myelogenous leukaemia lymphoid blast crisis
  • •3. Females who are pregnant or lactating
  • •4. History or presence of clinically relevant CNS pathology within 3 months prior to enrolment, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis
  • •5. Presence of CNS-3 disease or CNS-2 disease with neurological changes. Patients developing CNS Grade 3 disease or symptomatic CNS-2 disease at any time after enrolment will also be excluded
  • •6. Clinically significant, uncontrolled heart disease or a recent cardiac event
  • •7. Patients with a history or evidence of pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning
  • •8. Patients with active gastrointestinal bleeding
  • •9. Patients with any major surgical intervention in the last 3 months
  • •10. Active infectious bacterial or viral disease or fungal requiring treatment with i.v. antimicrobials
  • •11. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months. Any autoimmune disease with CNS involvement
  • •12. History of other malignant neoplasms unless disease free for at least 24 months
  • •13. History of concomitant genetic syndrome such as Fanconi anaemia, Shwachman-Diamond syndrome, Kostmann syndrome or any other known BM failure syndrome
  • •14. Stem cell transplant patients only: Active significant acute GVHD or moderate/severe chronic GVHD) requiring systemic s

研究者

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