Trial Search Results

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Juno Therapeutics, a Subsidiary of Celgene

Stanford Investigator(s):

Intervention(s):

  • Biological: lisocabtagene maraleucel

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maria Iglesias
650-736-0912
Not Recruiting