EUCTR2016-000296-24-GB进行中（未招募）1 期
Phase I, open label, dose-escalation study followed by a safety expansion part 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 30 人开始时间: 2016年2月24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
- 30
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
- •2a. Age = 16 years up to < 70 years
- •3a. Patient with relapsed or refractory CD19 positive B-acute lymphoblastic leukaemia (B-ALL) as per guidelines (National Comprehensive Cancer Network, 2019)
- •- morphologically confirmed with = 5% leukaemic blasts in the bone marrow,
- •- or presenting a quantifiable MRD load of 1x10-3, assessed by multiparameter flow cytometry and/or quantitative polymerase chain reaction, at the end of the last induction treatment
- •- who has exhausted alternative treatment options
- •Relapsed disease is defined as:
- •a. second or subsequent bone marrow relapse or,
- •b. any bone marrow relapse after allo-HSCT
- •Refractory disease is defined by not achieving an initial complete response (CR) after 2 cycles of a standard chemotherapy regimen (primary refractory). Subjects who were refractory to subsequent chemotherapy regimens after an initial remission were considered chemorefractory.
- •4. Estimated life expectancy = 12 weeks (according to investigator’s judgement).
- •5. Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •6b. Adequate organ functions including renal and hepatic function based on the last assessment performed within the Screening Period, defined as:
- •- creatinine clearance = 60 mL/min (as calculated using the standard method for the institution)
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN (upper limit of normal)
- •- Total bilirubin = 1.5 x ULN (except for patients with known history of Gilbert’s syndrome who are excluded if total bilirubin > 2.5 x ULN)
- •7b. Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to inclusion. Within the frame of this study, female participants of childbearing potential and male participants with partners of childbearing potential must use an effective method of birth control, as well as their partners, from the screening period up to 12 months after the last dose of UCART19 administration. Nonchildbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
- •50. Availability of a donor for potential allo-HSCT in the event of persistent marrow aplasia without evidence of residual leukaemia
- •8a. Written informed consent obtained prior to any study-specific procedure.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
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.
- •12a. Previous treatment with gene or gene-modified cell therapy medicine products or adoptive T cell therapy.
- •13a. Use of previous anti-leukaemic therapy (including approved therapies and other investigational products) within 5 half-lives prior to UCART19 administration; participation in non-interventional registries or epidemiological studies is allowed. Inotuzumab ozogamicin must be stopped at least 28 days prior to administration of UCART19.
- •49. Legally incapacitated person under guardianship or trusteeship.
- •14. CD19 negative B-cell leukaemia.
- •16. Burkitt cell (L3 ALL) or mixed lineage acute leukaemia.
- •36a. Clinically suspected extra-medullary involvement (except CNS-1, CNS-2 and isolated skin involvement).
- •39a.Evidence of disease progression after cytoreduction, if administered (e.g., significant increase of peripheral blast count)
- •40b.Presence of exclusion criteria for alemtuzumab administration:
- •- Patients with history of recurrent and significant viral infection
- •- Patients with history of thyroid dysfunction requiring medical intervention.
- •- Patients with grade 4 lymphopenia
- •- Patients with history of hypersensitivity to alemtuzumab.
- •- Patients with history of neutralizing anti-drug antibody against alemtuzumab
- •19a. Active CNS leukaemia(CNS-3)
- •20. Clinically active significant CNS dysfunction.
- •37b. Known history of irreversible severe neurological toxicity related to previous antileukaemic treatment leading to organic central nervous system lesions.
- •18. Radioimmunotherapy, radiotherapy, within 8 weeks (except prophylaxis of CNS involvement) before Inclusion.
- •21a. Allogeneic HSCT within 3 months prior Screening, any donor lymphocyte infusions that must be completed > 6 weeks prior to Screening
- •22a. 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 3 months prior to Screening.
- •23a. Presence of donor-specific anti-HLA antibodies directed against UCART19.
- •24a. Active acute or chronic GvHD requiring systemic therapy within 4 weeks of UCART19 infusion.
- •25a. Patient with autoimmune disease treated with immunosuppressive agents that cannot be stopped. Infliximab must be stopped at least 45 days prior to administration of UCART19.
- •64. Use of corticosteroids > 1mg/kg, within 5 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 systemic bacterial, fungal, protozoal or viral infection not controlled by adequate treatment, at Inclusion, and presence of positive blood cultures within 7 days before Inclusio
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