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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

    May 7, 2021

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Clinical Trial Information for Patients Visit BMS Study Connect

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. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

  • Condition or Disease:
  • Intervention/Treatment:
  • 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: September 2022
  • Estimated Study Completion Date: December 2027

Outcome Measures

Eligibility Criteria

  • Ages Eligible for Study:
  • Sexes Eligible for Study:
  • Accepts Healthy Volunteers:

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

More Information

  • Responsible Party:
  • ClinicalTrials.gov Identifier: NCT03331198 History of Changes
  • Other Study ID Numbers:
  • First Posted: November 6, 2017 Key Record Dates
  • Last Update Posted: May 7, 2021
  • Last Verified: April 2021

  • 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