©2024 Stanford Medicine
Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Not Recruiting
Trial ID: NCT03483103
Purpose
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.
Official Title
A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
Stanford Investigator(s)
Neel K. Gupta
Clinical Associate Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Eligibility
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
Intervention(s):
biological: lisocabtagene maraleucel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Iglesias
650-736-0912