jRCT1080225154已完成2 期
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
- •Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
- •Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
- •Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
- •Adequate vascular access for leukapheresis procedure
排除标准
- •Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
- •WHO subclassification of duodenal-type FL
- •Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
- •History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
- •Prior CAR T-cell or other genetically-modified cell therapy
- •History of or active human immunodeficiency virus (HIV)
- •Active hepatitis B or active hepatitis C
- •Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
- •Active autoimmune disease requiring immunosuppressive therapy
- •Presence of acute or chronic graft-versus-host=disease
- •History of significant cardiovascular disease
- •History or presence of clinically relevant central nervous system pathology
- •Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis
结局指标
主要结局
-
1. Overall Response Rate (ORR) as assessed but PET-CT and/or CT using "The Lugano Classification"
次要结局
- Progression-Free Survival (PFS)
- Complete response rate (CRR)
- Duration of Response (DOR) if Best Overall Response (BOR) is CR
- Duration of Response (DOR)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy andSafety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-HodgkinLymphomaJPRN-jRCT1080225154Bristol-Myers Squibb K.K.18
已完成
2 期
A Phase 1/2, open-label, single arm, multicohort, multicenter trial to evaluate the safety and efficacy of JCAR017 in pediatric subjects with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL) (TRANSCEND PEDALL)NL-OMON48667Celgene Corporation5
进行中（未招募）
1 期
A study for subjects with Epstein-Barr Virus-associated Diseases• EBV+ primary imunodeficiency lymphoproliferative disease (LPD)• EBV+ associated lymphoproliferative disease in the setting of acquired (non-congenital) immunodeficiency (EBV+ AID LPD)• EBV+ associated post-transplant LPD involving the central nervous system (EBV+ CNS PTLD)• EBV+ post-transplant LPD where standard first line therapy (rituximab or chemotherapy) is inappropriate, including CD20-negative disease• EBV+ sarcomas, including leiomyosarcoma, or smooth muscle tumorsMedDRA version: 27.0Level: PTClassification code 10068349Term: Epstein-Barr virus associated lymphoproliferative disorderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000177-25-BEAtara Biotherapeutics, Inc.190
进行中（未招募）
1 期
A study for subjects with Epstein-Barr Virus-associated DiseasesEUCTR2020-000177-25-FRAtara Biotherapeutics, Inc.228
进行中（未招募）
1 期
A study for subjects with Epstein-Barr Virus-associated Diseases• EBV+ primary imunodeficiency lymphoproliferative disease (LPD)• EBV+ LPD in the setting of acquired (non-congenital) immunodeficiency• EBV+ post-transplant LPD involving the central nervous system• EBV+ post-transplant LPD where standard first line therapy (rituximab or chemotherapy) is not appropriate, including CD20-negative disease• EBV+ sarcomas, including leiomyosarcoma• Chronic active Epstein-Barr virus and EBV+ hemophagocytic lymphohistiocytosisMedDRA version: 21.1Level: PTClassification code 10068349Term: Epstein-Barr virus associated lymphoproliferative disorderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000177-25-ITAtara Biotherapeutics Inc.228