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

  • Interventional
  • Not Recruiting
  • NCT03483103
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03483103

IRB#IRB19-1255

Lead SponsorJuno Therapeutics, Inc.

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting