OncRef

Clinical Trial: 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)

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Celgene
Information Provided By:Celgene
Last Update Posted:2025-11-05

Study Overview

Brief 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.

Official Title

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)

Conditions

Lymphoma, Non-Hodgkin

Intervention / Treatment

  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: JCAR017

Other Study ID Numbers

  • JCAR017-FOL-001
  • U1111-1244-9768
  • 2024-510966-18

Start Date (Actual)

2020-07-14

Primary Completion Date (Estimated)

2031-09-30

Study Completion Date (Estimated)

2031-09-30

Enrollment (Estimated)

276

Study Type

Interventional

Phase

Phase 2