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)

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT03744676
Run by: Juno Therapeutics, a Subsidiary of Celgene
People needed: 104
Starts: 2018-11-29
Expected to finish: 2023-09-22
Last updated by the study team: 2025-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Local Institution - 0057 — Los Angeles, California, United States
Local Institution - 0060 — Denver, Colorado, United States
Local Institution - 0089 — Miami, Florida, United States
Local Institution - 0081 — Orlando, Florida, United States
Local Institution - 0065 — Indianapolis, Indiana, United States
Local Institution - 0069 — Wichita, Kansas, United States
Local Institution - 0064 — Louisville, Kentucky, United States
Local Institution - 0101 — Southfield, Michigan, United States
Local Institution - 0052 — East Brunswick, New Jersey, United States
Local Institution - 0066 — Morristown, New Jersey, United States
Local Institution - 0041 — Albany, New York, United States
Local Institution - 0039 — Cincinnati, Ohio, United States
Local Institution - 0098 — Eugene, Oregon, United States
Local Institution - 0051 — Portland, Oregon, United States
Lancaster General Hospital — Lancaster, Pennsylvania, United States
Local Institution - 0037 — Greenville, South Carolina, United States
Local Institution - 0063 — Nashville, Tennessee, United States
Local Institution - 0097 — Dallas, Texas, United States
Local Institution - 0061 — San Antonio, Texas, United States
Baylor Scott and White Health — Temple, Texas, United States
Local Institution - 0096 — Tyler, Texas, United States
Local Institution - 0074 — Salt Lake City, Utah, United States
Local Institution - 0036 — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.