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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/10/2020.
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Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Clinicaltrials.gov identifier NCT03331198

Recruitment Status Recruiting

First Posted November 6, 2017

Last update posted June 2, 2020

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study description
Study Description

Brief summary:

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

  • Condition or Disease:Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoma, Small Lymphocytic
  • Intervention/Treatment: Biological: JCAR017 (lisocabtagene maraleucel)
    Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib
  • Phase: Phase 1/Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 200 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
  • Actual Study Start Date: December 2017
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: July 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Phase 1 JCAR017 monotherapy
Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)		 Biological: JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 2 JCAR017 monotherapy
Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm		 Biological: JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + ibrutinib
Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose + ibrutinib		 Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Outcome Measures
  • Primary Outcome Measures: 1. Phase 1 monotherapy arm: recommended dose [ Time Frame: 28 days ]
    Recommended dose based on assessment of data from each dose level
  • 2. Phase 1 combination therapy arm: adverse events [ Time Frame: Through post-treatment Month 24 ]
    Proportion of subjects experiencing adverse events
  • 3. Phase 1 combination therapy arm: laboratory abnormalities [ Time Frame: Through post-treatment Month 24 ]
    Proportion of subjects experiencing laboratory abnormalities
  • 4. Phase 2: rate of complete remission (CR) [ Time Frame: Through post-treatment Month 24 ]
    Proportion of subjects who have CR after JCAR017 infusion based on Independent Review Committee (IRC) assessment using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines
  • Secondary Outcome Measures: 1. Phase 2: overall response rate [ Time Frame: Through post-treatment Month 24 ]
    Overall response rate based on IRC assessment using iwCLL 2018 guidelines
  • 2. Phase 2: minimal residual disease (MRD)-negative response rate [ Time Frame: Through post-treatment Month 24 ]
    MRD will be measured via IgHV deep sequencing and flow cytometry of peripheral blood
  • 3. Phase 2: adverse events [ Time Frame: Through post-treatment Month 24 ]
    Proportion of subjects experiencing adverse events
  • 4. Phase 2: laboratory abnormalities [ Time Frame: Through post-treatment Month 24 ]
    Proportion of subjects experiencing laboratory abnormalities
  • 5. Phase 2: overall survival [ Time Frame: Through post-treatment Month 24 ]
    Overall survival
  • 6. Phase 2: progression-free survival (PFS) [ Time Frame: Through post-treatment Month 24 ]
    PFS, defined as the time from JCAR017 infusion to disease progression or death
  • 7. Phase 2: health economics and outcomes research [ Time Frame: Through post-treatment Month 24 ]
    EuroQol instrument EQ-5D-5L and numbers of intensive care unit (ICU) inpatient days and non-ICU inpatient days
  • 8. Phase 2: health-related quality of life [ Time Frame: Through post-treatment Month 24 ]
    EORTC QLQ-C30
  • 9. Phase 2: health-related quality of life [ Time Frame: Through post-treatment Month 24 ]
    CLL-specific module QLQ-CLL-17
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Diagnosis of:

1. CLL with an indication for treatment based on the Investigator's opinion and
measurable disease, or

2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [ 30 mL/min

2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or 20 mg/day prednisone or
equivalent) within 7 days prior to leukapheresis

10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis

11. Venetoclax within 4 days prior to leukapheresis

12. Idelalisib or duvelisib within 2 days prior to leukapheresis

13. Lenalidomide within 1 day prior to leukapheresis

14. Experimental agents, including off-label use of approved drugs (with the
exception of acalabrutinib which may be continued up to the day before
leukapheresis), within 4 weeks prior to leukapheresis unless progression is
documented on the experimental therapy and at least 3 half-lives have elapsed
prior to leukapheresis

- Uncontrolled medical, psychological, familial, sociological, or geographical
conditions that do not permit compliance with the protocol, as judged by the
Investigator; or subject unwillingness or inability to follow the procedures required
in the protocol

- Progressive vascular tumor invasion, thrombosis, or embolism

- Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation

Contacts and Locations
Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Show 34 Study Locations
Sponsors and Collaborators

Juno Therapeutics, a Subsidiary of Celgene

Investigators

Study Director: Heidi Gillenwater, MD Juno Therapeutics, Inc.

More Information
  • Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
  • ClinicalTrials.gov Identifier: NCT03331198 History of Changes
  • Other Study ID Numbers: 017004, TRANSCEND-CLL-004
  • First Posted: November 6, 2017 Key Record Dates
  • Last Update Posted: June 2, 2020
  • Last Verified: June 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Juno Therapeutics, a Subsidiary of Celgene: CLL
    SLL
    JCAR017
    chimeric antigen receptor
    chronic lymphocytic leukemia     small lymphocytic lymphoma
    CAR
    CAR T cells
    autologous T cell therapy
    immunotherapy
  • Additional relevant MeSH terms: Leukemia
    Lymphoma     Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
= Our trial