NCT04245839

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine
DRUG	Cyclophosphamide	Cyclophosphamide
DRUG	JCAR017	JCAR017

Timeline

• Start date: 2020-07-14
• Primary completion: 2031-09-30
• Completion: 2031-09-30
• First posted: 2020-01-29
• Last updated: 2025-11-05

Locations

49 sites across 10 countries: United States, Austria, Canada, France, Germany, Italy, Japan, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study