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

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)

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

- Nursing women

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

- Prior hematopoietic stem cell transplant