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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This single-arm, multicenter Phase 2 trial will treat adult patients who have relapsed or refractory B-ALL with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to leukemia cells that express the CD19 protein on the cell surface. The study will determine if these modified T cells (called JCAR015) help the body's immune system eliminate leukemia cells. The trial will also study the safety of treatment with JCAR015, how long JCAR015 cells stay in the patient's body, the extent to which JCAR015 eliminates minimal residual disease, and the impact of this treatment on survival.

Official Title

A Phase 2, Single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Details

This is a single-arm, multicenter Phase 2 study to determine the efficacy and safety of JCAR015 in adult patients with relapsed or refractory B-ALL. The study will have the following sequential phases: Part A (screening, leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B (treatment and follow-up). The follow-up period for each participant is approximately 12 months after the final JCAR015 infusion. The total duration of the study is expected to be approximately 3 years. Long-term follow-up for survival, toxicity, and viral vector safety will continue under a separate long-term follow-up protocol per health regulatory authority guidelines, currently up to 15 years after the last JCAR015 infusion.

Keywords

Acute Lymphoblastic Leukemia ALL chimeric antigen receptor CAR CAR T cells JCAR015 autologous T cell therapy cell therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18 years at the time of consent
  2. Relapsed or refractory B-ALL, defined as:

    • First or greater bone marrow relapse from CR, or
    • Any bone marrow relapse after allogeneic hematopoietic stem cell transplant(HSCT); subjects must be at least 100 days from HSCT at the time of screening and off immunosuppressant medication for at least 1 month at the time of screening, and have no active graft-vs-host disease (GVHD), or
    • Refractory B-ALL, defined by not having achieved a CR or CRi after two attempts at remission induction using standard regimens, or
    • Ph+ B-ALL if subjects are intolerant to or ineligible for tyrosine kinase inhibitor (TKI) therapy, or have progressed after at least one line of TKI therapy
  3. Morphological evidence of disease in bone marrow (at least 5% blasts)
  4. Evidence of CD19 expression
  5. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2 at the time of screening
  6. Adequate pulmonary, renal, hepatic, and cardiac function
  7. Adequate central or peripheral vascular access for leukapheresis procedure

You CAN'T join if...

  1. Isolated extramedullary disease relapse
  2. Concomitant genetic syndrome or other known bone marrow failure syndrome
  3. Burkitt's lymphoma/leukemia or chronic myelogenous leukemia lymphoid blast crisis(p210 BCR-ABL+)
  4. Prior malignancy, unless treated with curative intent and with no evidence of active disease present for> 5 years before screening
  5. Prior treatment with any gene therapy product
  6. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV)infection at the time of screening
  7. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening
  8. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
  9. Active central nervous system (CNS) involvement by malignancy (defined as CNS-3 per National Comprehensive Cancer Network [NCCN] guidelines)
  10. 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(NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
  11. History or presence of clinically relevant CNS pathology such as epilepsy,generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries,dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  12. Participation in an investigational research study using an investigational agent within 30 days of screening
  13. History of treatment with a murine-derived biological product other than blinatumomab unless subject has been shown to be negative for human-anti-mouse-antibodies (HAMA)prior to or during screening
  14. Pregnant or nursing women
  15. Use of prohibited medications:
  16. Steroids: Therapeutic doses of corticosteroids are prohibited within 7 days prior to leukapheresis.
  17. Allogeneic cellular therapy: Donor lymphocyte infusions (DLI) are prohibited within 4 weeks prior to leukapheresis
  18. GVHD therapies: Any drug used for GVHD within 4 weeks prior to leukapheresis
  19. Chemotherapies: Salvage chemotherapy must be stopped at least 1 week prior to leukapheresis
  20. Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis

Locations

  • City of Hope
    Duarte, California, 91010, United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc.
ID
NCT02535364
Phase
Phase 2
Lead Scientist
Gabriel Mannis
Study Type
Interventional
Last Updated
August 1, 2016
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