EUCTR2016-000296-24-FR进行中（未招募）1 期
Phase I, open label, dose-escalation study to evaluate the safety, expansion and persistence of a single dose of UCART19 (allogeneic engineered T-cells expressing anti-CD19 chimeric antigen receptor), administered intravenously in patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukaemia (B-ALL)). - CALM study
Institut de Recherches Internationales Servier (I.R.I.S)0 个研究点目标入组 18 人开始时间: 2017年10月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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. Male or female participant
- •2. Age = 16 years
- •3. Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL).
- •4. Estimated life expectancy = 12 weeks (according to investigator’s judgement).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •6. Adequate organ functions including renal and hepatic function based on the last assessment performed within the Screening Period, defined as:
- •- creatinine clearance = 30 mL/min (assessed as GFR using the Cockcroft & Gault formula)
- •- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 x ULN (upper limit of normal)
- •- Total bilirubin < 1.5 x ULN (Except Gilbert’s Syndrome confirmed by UGT1A1 gene mutation)
- •7. Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to inclusion.
- •8. Written informed consent obtained prior any study-specific procedure.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •10. Women who are lactating.
- •35. Patients unwilling to undergo a safety follow-up for 15 years
- •11. Foreseeable poor compliance to the study procedures.
- •12. Previous treatment with investigational gene or cell therapy medicine products.
- •13. Use of other investigational products or other anti-leukaemic therapy within 5 half-lives or within 14 days prior to UCART19 administration, whichever is a shorter duration, participation in non-interventional registries or epidemiological studies is allowed.
- •14. CD19 negative B-cell leukaemia.
- •16. Burkitt cell (L3 ALL) or mixed lineage acute leukaemia.
- •36. Clinically suspected extra-medullary involvement.
- •19. Active CNS leukaemia.
- •20. Clinically active significant CNS dysfunction.
- •37. Previous severe neurological toxicity related to blinatumomab.
- •18. Radioimmunotherapy, radiotherapy, within 8 weeks (except prophylaxis of CNS involvement) before Inclusion.
- •21. Autologous HSCT within 6 weeks or allogeneic HSCT within 3 months prior Screening.
- •22. Use of rituximab and other anti CD 20 antibodies known to have the same epitope as rituximab or anti CD20 for which the epitope is unknown within 6 months prior to Screening.
- •23. Presence of donor-specific anti-HLA antibodies.
- •24. Active acute or chronic GvHD requiring therapy.
- •25. Patient with autoimmune disease treated with immunosuppressive agents, e.g. corticosteroids > 1 mg/kg, within 5 days prior to administration of UCART19. Infliximab must be stopped at least 45 days prior to administration of UCART19.
- •26. A known hypersensitivity to any of the test materials or related compounds including murine and bovine products.
- •27. Any known uncontrolled cardiovascular disease or any of the following in the previous 6 months before Inclusion: ventricular or atrial dysrhythmia = grade 2, bradycardia = grade 2, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, hypertension not adequately controlled by standard medications. In addition, left ventricular ejection fraction (LVEF) < 45% assessed by echocardiography or Multi Gated Acquisition Scan (MUGA) assessed at Screening.
- •28. History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
- •29. Active bacterial, fungal, protozoal or viral infection not controlled by adequate treatment, at Inclusion, and presence of positive blood cultures within 7 days before Inclusion
- •30. Any major surgery within 3 months prior to Screening.
- •31. Abnormal findings during the Screening period, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient’s safety.
- •32. Any planned medical/surgical treatment that might interfere with the ability to comply with the study requirements.
- •33. Evidence of another malignancy within 2 years prior to Screening (except in situ basal or squamous cervix or skin cell carcinoma).
- •34. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •38. Patients tested positive for human immunodeficiency virus (HIV) and/or human T-lymphotropic virus (HTLV), at Inclusion
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