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

• Status: Recruiting
• Trial end date: 2024-04-29

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 2 years.

• Phase: Phase 2

Details

• Lead Sponsor: Celgene
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate