MedTrace Logo

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

NCT03744676 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-02-27

Study results available
· View outcomes & findings →

Summary

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

Conditions

  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Neoplasms
  • Neoplasms by Histologic Type
  • Lymphoproliferative Disorders
  • Lymphatic Diseases
  • Immunoproliferative Disorders
  • Immune System Disorder

Interventions

BIOLOGICAL

lisocabtagene maraleucel

lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Juno Therapeutics, a Subsidiary of Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2023-09-22
Completion
2023-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744676 on ClinicalTrials.gov