Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • An Open-Label, Phase 1/2 Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2019-024
    NCT ID
    • NCT03331198
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I/II
    Principal Investigator
    • Abhinav
      Deol, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Phase 1 Monotherapy (open-label, single-arm, dose-finding for JCAR017 monotherapy):

    Primary Objective(s):
    • To evaluate the safety and to determine the RD of JCAR017 in subjects with R/R CLL or SLL
    Phase 1 Combination (open-label, single-arm, dose-finding for ibrutinib + JCAR017 combination in subjects continuing with ibrutinib treatment):

    Primary Objective(s):
    • To evaluate the safety of ibrutinib + JCAR017 and to determine the RD of JCAR017 in combination with ibrutinib in subjects with R/R CLL or SLL
    Phase 2 Expansion (open-label, single-arm, expansion of JCAR017 monotherapy at RD):

    Primary Objective(s):
    • To evaluate antitumor activity of JCAR017 monotherapy at the RD in subjects with R/R CLL or SLL as determined by complete remission (CR) rate (including complete remission with incomplete marrow recovery [CRi]) based on independent review using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines
    Secondary Objective(s):
    • To evaluate the safety and tolerability of JCAR017 monotherapy at the RD in subjects with R/R CLL or SLL
    • To assess the depth and durability of antitumor activity of JCAR017 monotherapy at the RD in subjects with R/R CLL or SLL
    • To estimate the effect of JCAR017 monotherapy at the RD on disease progression and survival
    • To assess health-related quality of life (HRQoL) in subjects with R/R CLL or SLL treated with JCAR017 monotherapy at the RD
    • To assess health economics and outcomes research (HEOR) in subjects with R/R CLL or SLL treated with JCAR017 monotherapy at the RD
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 800-527-6266