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An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

Clinical Trial Details

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 (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This trial is open to men and women age 18 and older CLL or SLL. 

There are no standard treatment options for subjects with late-stage, relapsed or refractory (R/R) CLL who have failed treatment with Bruton tyrosine kinase inhibitors (BTKis) such as ibrutinib. Therefore, the purpose of the Phase 1 monotherapy portion of this study is to evaluate the safety, recommended dose (RD), antitumor activity, and pharmacokinetics (PK) of JCAR017 treatment in subjects with R/R CLL or SLL. The purpose of Phase 1 Combination of this study is 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. The purpose of Phase 2 of this study is to evaluate antitumor activity of JCAR017 monotherapy at the RD compared to standard of care in subjects with R/R CLL or SLL.

The enrollment period is expected to take 12-24 months and the follow-up period for each subject is approximately 24 months after the last dose of JCAR017 or the start of standard-of-care treatment. 

Key Eligibility: 
  • Men and women age 18 and older. 
  • Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed BTKi treatment or have been deemed ineligible for BTKi therapy. 
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received previous treatment as follows: 
  1. Subjects with CLL or SLL and high-risk features, must have failed at least 2 lines of prior  therapy, including a BTKi. 
  2. Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy, including a BTKi. 
  3. Subjects with CLL or SLL who are BTKi intolerant and have not received at least 6 months of BTKi therapy or are ineligible for BTKi must have failed at least 1 (high-risk) or 2 (standard-risk) lines of non-BTKi therapy. 

Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1709018599

Status

Open to Enrollment

Age Group

Adult

Sponsor