OncRef

Clinical Trial: NCT03331198

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Juno Therapeutics, a Subsidiary of Celgene
Information Provided By:Juno Therapeutics, a Subsidiary of Celgene
Last Update Posted:2026-07-06

Study Overview

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.

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)

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Small Lymphocytic

Intervention / Treatment

  • Biological: JCAR017 (lisocabtagene maraleucel)
  • Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib
  • Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax

Other Study ID Numbers

  • 017004
  • TRANSCEND-CLL-004

Start Date (Actual)

2017-11-27

Primary Completion Date (Estimated)

2027-11-26

Study Completion Date (Estimated)

2027-11-26

Enrollment (Estimated)

320

Study Type

Interventional

Phase

Phase 1, Phase 2