Last updated on December 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diffuse Large B-Cell Lymphoma | Lymphoma | B-Cell Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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
  • Tumor invasion of venous or arterial vessels
  • Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 3 months of leukapheresis and/or DVT or PE that requires ongoing therapeutic levels of anticoagulation

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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