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.
Detailed eligibility reviewed when you contact the study team.