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Clinical Trials
NCT03483103

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)

Last Updated: 2023-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2022-12-01

Brief Summary

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This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin Lymphoma, Nonhodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

Keywords

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JCAR017 lisocabtagene maraleucel NHL chimeric antigen receptor CAR CAR T cell autologous T cell therapy immunotherapy cell therapy liso-cel

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Lisocabtagene maraleucel at a dose of 100×10\^6 CAR+ T cells (50×10\^6 CD8+ CAR+ T cells and 50×10\^6 CD4+ CAR+ T cells), will be given IV in a single-dose schedule on Day 1 (between 2 and 7 days following the completion of lymphodepleting chemotherapy).

Group Type EXPERIMENTAL

lisocabtagene maraleucel

Intervention Type BIOLOGICAL

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

Interventions

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lisocabtagene maraleucel

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

Intervention Type BIOLOGICAL

Other Intervention Names

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JCAR017 liso-cel

Eligibility Criteria

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Inclusion Criteria

* Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma \[tFL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma \[DHL/THL\]), and follicular lymphoma Grade 3B per WHO 2016 classification
* Previous treatment must include treatment with a single line of chemoimmunotherapy containing an anthracycline and a CD20-targeted agent
* Subjects must be deemed ineligible for both high-dose chemotherapy and hematopoietic stem cell transplant (based on age, performance status and/or comorbidities) while also having adequate organ function for CAR T cell treatment.
* Positron emission tomography (PET)-positive disease
* Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
* ECOG performance status of 0, or 1, or 2
* Adequate vascular access for leukapheresis procedure (either peripheral line or surgically-placed line)
* Subjects must agree to use appropriate contraception
* Subjects must agree to not donate blood, organs, semen, and egg cells for usage in other individuals for at least 1 year following lymphodepleting chemotherapy

Exclusion Criteria

* Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
* History of another primary malignancy that has not been in remission for at least 2 years.
* Previous treatment with CD19-targeted therapy, with the exception of prior lisocabtagene maraleucel treatment in this protocol for subjects receiving retreatment
* Active hepatitis B or hepatitis C infection at the time of screening
* History of or active human immunodeficiency virus (HIV) infection at the time of screening
* Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or lisocabtagene maraleucel administration
* History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
* History or presence of clinically relevant CNS pathology
* Pregnant or nursing women
* Subject does not meet protocol-specified washout periods for prior treatments
* Prior hematopoietic stem cell transplant
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Local Institution - 0043

Gilbert, Arizona, United States

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

UNC School of Medicine

Los Angeles, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

Sutter Hematology and Oncology

Sacramento, California, United States

Site Status

Sutter Medical Center

Sacramento, California, United States

Site Status

Stanford Cancer Genetics Clinic

Stanford, California, United States

Site Status

Local Institution - 0092

Stanford, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Local Institution - 0019

Atlanta, Georgia, United States

Site Status

The Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status