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Active, Not Recruiting

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) - 017007

Updated: 1 March, 2023   |

Juno Therapeutics and Celgene are wholly owned subsidiaries of Bristol-Myers Squibb Company

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2


  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
Experimental: Lisocabtagene maraleucel
Biological: lisocabtagene maraleucel

Key Eligibility Criteria

Inclusion Criteria: - Age ≥ 18 years at the time of consent - Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT. - Positron-emission tomography-positive disease by Lugano Classification - Eastern Cooperative Oncology Group performance status of 0 to 1 - Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function - Adequate vascular access for leukapheresis procedure - Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy - Subjects must agree to use appropriate contraception. Exclusion Criteria: - Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study) - History of prior allogeneic hematopoietic stem cell transplant - Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis - History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear. - Active hepatitis B or hepatitis C infection at the time of screening - History of or active human immunodeficiency virus infection at the time of screening - Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration - Presence of acute or chronic graft-versus-host disease - History of clinically significant cardiac conditions within the past 6 months - History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis - Pregnant or nursing women - Subject does not meet protocol-specified washout periods for certain prior treatments - Prior CAR T-cell or other genetically modified T-cell therapy - Progressive vascular tumor invasion, thrombosis, or embolism - Venous thrombosis or embolism not managed on stable regimen of anticoagulation - Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email