Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Phase 1/2 Active not recruiting 320 enrolled Juno Therapeutics, a Subsidiary of Celgene

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-11-27
Primary completion: 2027-11-26
Completion: 2027-11-26

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	—	—
Subject	Lisocabtagene Maraleucel	Cell therapy	5e+07 cells	Intravenous
Subject	Lisocabtagene Maraleucel	Cell therapy	1e+08 cells	Intravenous
Subject	Venetoclax	Small molecule	—	—

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Summary

Timeline

Publications

Drugs

Indications