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临床试验/jRCT2063230095
jRCT2063230095进行中（未招募）不适用

A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects with Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (JKART-1)

Gilead Sciences K.K.0 个研究点目标入组 21 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
21
主要终点
Objective response rate (ORR) (CR + PR)
研究概览研究设计入排标准结局指标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
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
All

入选标准

  • •<MCL Cohort>
  • •Pathologically confirmed MCL with documentation or either overexpression of cyclin D1 or presence of t(11;14)
  • •Up to 5 prior regimens for MCL. Prior therapy must have included:
  • •Anthracycline-, bendamustine-, or high-dose cytarabine- containing chemotherapy, and
  • •Anti-CD20 monoclonal antibody therapy, and
  • •Bruton's tyrosine kinase inhibitor (BTKi)
  • •Relapsed or refractory disease, defined by the following:
  • •Disease progression after last regimen, or
  • •Refractory disease is defined failure to achieve partial response (PR) or complete response (CR) to the last regimen
  • •At lease 1 measurable lesion
  • •Toxicities due to prior therapy must be stable and recovered to <= Grade 1
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • •Adequate bone marrow function as indicated by:
  • •Absolute neutrophil count (ANC) >= 1,000/microL
  • •Platelet count >= 75,000/microL. For subjects with bone marrow involvement, platelet count >= 50,000/microL is acceptable.
  • •Absolute lymphocyte count >= 100/microL
  • •Adequate renal, hepatic, pulmonary, and cardiac function defined as:
  • •Creatinine clearance (CrCl) or eCrCl by Cockcroft Gault >= 60 cc/min
  • •Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2.5 upper limit of normal (ULN)
  • •Total bilirubin <=1.5 mg/dl, except in subjects with Gilbert's syndrome
  • •Cardiac ejection fraction >= 50%, no evidence of significant pericardial effusion, and no clinically significant electrocardiogram (ECG) findings.
  • •No clinically significant pleural effusion
  • •Baseline oxygen saturation > 92% on room air
  • •<ALL Cohort>
  • •Relapsed or refractory B-ALL defined as one of the following:
  • •Relapsed or refractory disease after one line of systemic therapy:
  • •Primary refractory, or
  • •First relapse if first remission <=12 months
  • •Relapsed or refractory disease after two or more lines of systemic therapy
  • •Relapsed or refractory disease after allogenic transplant provided subject is at least 100 days from SCT at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
  • •Morphological disease in the bone marrow (> 5% blasts)
  • •Subjects with Ph+ disease are eligible if they are intoleratnt to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/ refractory disease despite treatment with at least 2 different TKIs
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • •Adequate bone marrow function as indicated by:
  • •Absolute neutrophil count (ANC) >= 500/microL
  • •Platelet count >= 50,000/microL unless in the opinion of the investigator cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy.
  • •Absolute lymphocyte count >= 100/microL
  • •Adequate renal, hepatic, pulmonary, and cardiac function defined as:
  • •CrCl or eCrCl by Cockcroft Gault >= 60 cc/min
  • •Serum ALT, AST <= 2.5 x ULN
  • •Total bilirubin <= 1.5 mg/dl, except in subjects with Gilbert's syndrome
  • •Left ventricular ejection fraction >= 50%, no evidence of significant pericardial effusion, no NYHA class III/IV functional classification, and no clinically significant arrhythmias.
  • •No clinically significant pleural effusion
  • •Baseline oxygen saturation > 92% on room air
  • •In subjects previously treated with blinatumab, CD19 tumor expression on blasts obtained from bone marrow or peripheral blood is documented after completion of the most recent prior line of therapy

排除标准

  • •<MCL Cohort>
  • •History of malignancy other than non-melanomatous skin cancer or carcinoma in situ unless disease-free for at least 3 years
  • •Autologous stem cell transplant (autoSCT) within 6 weeks of planned KTE-X19 infusion
  • •History of allogenic stem cell transplant (alloSCT) with the exception of subjects with no donor cells detected on chimerism > 100 days after alloSCT
  • •Prior CD19 targeted therapy
  • •Prior CAR therapy or other genetically modified T-cell therapy
  • •Infection with immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • •Subjects with detectable cerebraospinal fluid (CSF) malignant cells or brain metastases or with a history of Central Nervous System (CNS) lymphoma, CSF malignant cells, or brain metastases
  • •Subjects with atrial or cardiac ventricular lymphoma involvement
  • •<ALL Cohort>
  • •History of malignancy other than non-melanoma skin cancer or carcinoma in situ (unless disease free for at least 3 years)
  • •CNS abnormalities
  • •Presence of CNS-2 or CNS-3 disease (those with CNS-1 or CNS-2 without clinically evident neurological changes are eligible to participate in the study)
  • •History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema within the last 2 years
  • •Infection with HIV, HBV, or HCV
  • •Those with the below prior medications:
  • •Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to enrollment
  • •Prior CD19 directed therapy other than blinatumomab
  • •History of Grade 4 neurologic event or Grade 4 CRS {Lee 2019} with prior CD19-directed therapy
  • •Any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment
  • •Acute graft versus host disease (GVHD) Grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment

结局指标

主要结局

Objective response rate (ORR) (CR + PR)

per the Lugano Classification {Cheson 2014} per investigator assessment

Overall complete remission (OCR) rate (CR + complete remission with incomplete hematological recovery [CRi])

per investigator assessment

次要结局

  • alloSCT rate

研究者

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