JPRN-jRCT2063230095招募中2 期
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
Asou Hiroya0 个研究点目标入组 21 人开始时间: 2024年1月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •- 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
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- 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
- •- 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
- •- 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
- •- 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
- •- 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
- •- 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
- •- Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with >= 5 WBCs per mm3 with or without neurological changes, and
- •- Presence of CNS-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with <5 WBCs per mm3 with neurological changes
- •- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, or cerebral edema within the last 2 years
- •- 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
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