Search Cancer Clinical Trials
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.
- Lymphoma, Non-Hodgkin
- Overall Response Rate (ORR)
- Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
- Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
- Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
- Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
- Overall Survival (OS)
- Adverse Events (AEs)
- Pharmacokinetics - Cmax
- Pharmacokinetics - Tmax
- Pharmacokinetics - AUC
- European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
- Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)
July 14, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
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)
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.