OncRef

Clinical Trial: NCT02631044

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Juno Therapeutics, a Subsidiary of Celgene
Information Provided By:Juno Therapeutics, a Subsidiary of Celgene
Last Update Posted:2024-06-27

Study Overview

Brief Summary

This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL. The dose and schedule of JCAR017 will be evaluated and modified, as needed, for safety and antitumor activity. We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma whose disease has come back or has not responded to treatment.

Official Title

A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

Conditions

Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle-cell Lymphoma, Primary Mediastinal B-cell Lymphoma

Intervention / Treatment

  • Biological: JCAR017 (lisocabtagene maraleucel) single-dose schedule
  • Biological: JCAR017 (lisocabtagene maraleucel) 2-dose schedule

Other Study ID Numbers

  • 017001

Start Date (Actual)

2016-01-06

Primary Completion Date (Actual)

2024-05-16

Study Completion Date (Actual)

2024-05-16

Enrollment (Actual)

387

Study Type

Interventional

Phase

Phase 1