Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-NHL-006)

Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:July 26, 2018
End Date:December 30, 2021
Contact:Juno Medical Information
Phone:866-599-JUNO (5866)

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A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)

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.

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

- 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

- ECOG performance status of 0, or 1, or 2

- Adequate vascular access for leukapheresis procedure (either peripheral line or
surgically-placed line)

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

- 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

- 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

- Nursing women

- Subject does not meet protocol-specified washout periods for prior treatments

- Prior hematopoietic stem cell transplant
We found this trial at
Gilbert, Arizona 85234
Principal Investigator: Javier L Munoz, MD, MS, FACP
Gilbert, AZ
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Baltimore, Maryland 21231
Principal Investigator: Nina Wagner-Johnston, MD
Phone: 410-614-0482
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
Baltimore, MD
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: John Godwin, MD
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
Portland, OR
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Lexington, Kentucky
Principal Investigator: Gerhard Hildebrandt, MD
Phone: 859-257-3379
Lexington, KY
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Alison Sehgal, MD
Phone: 412-623-6037
Pittsburgh, PA
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