临床试验/NCT04245839

NCT04245839进行中（未招募）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)

Celgene49 个研究点分布在 10 个国家目标入组 276 人开始时间: 2020年7月14日最近更新: 2025年11月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: Celgene
入组人数: 276
试验地点: 49
主要终点: Overall Response Rate (ORR)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

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

研究组 & 干预措施

Administration of JCAR017

Experimental

Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.

干预措施: Fludarabine (Drug)

Administration of JCAR017

Experimental

Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.

干预措施: Cyclophosphamide (Drug)

Administration of JCAR017

Experimental

Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.

干预措施: JCAR017 (Drug)

结局指标

主要结局

Overall Response Rate (ORR)

时间窗: Up to 60 months

Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"

次要结局

Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"(Up to 60 months)
Pharmacokinetics - Tmax(Up to 60 months)
Pharmacokinetics - AUC(Up to 60 months)
Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)(Up to 24 months)
Adverse Events (AEs)(Up to 60 months)
Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"(Up to 60 months)
Overall Survival (OS)(Up to 60 months)
Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"(Up to 60 months)
Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"(Up to 60 months)
Pharmacokinetics - Cmax(Up to 60 months)
European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)(Up to 24 months)

研究者

发起方

Celgene

申办方类型

Industry

责任方

Sponsor

研究点 (49)

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