Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: - Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; - Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; - Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.

Official Title

A Phase 2, Open-label, Single Arm, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Keywords

Lymphoma, Non-Hodgkin B-cell Non-Hodgkin Lymphoma (NHL) JCAR017 Relapsed or Refractory Lymphoma Lymphoma, B-Cell Cyclophosphamide Fludarabine Administration of JCAR017

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
  2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
  3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one or two prior lines of systemic therapy are eligible if they present with high risk features. Patients that received three or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ function
  7. Adequate vascular access for leukapheresis procedure

You CAN'T join if...

  1. Evidence of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
  2. WHO subclassification of duodenal-type FL
  3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
  4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
  5. Prior CAR T-cell or other genetically-modified T-cell therapy
  6. History of or active human immunodeficiency virus (HIV)
  7. Active hepatitis B or active hepatitis C
  8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
  9. Active autoimmune disease requiring immunosuppressive therapy
  10. . Presence of acute or chronic graft-versus-host=disease
  11. . History of significant cardiovascular disease
  12. . History or presence of clinically relevant central nervous system pathology

Locations

  • UCLA Medical Centre-Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Providence Cancer Center - Earle A. Chiles Research Institute accepting new patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT04245839
Phase
Phase 2
Study Type
Interventional
Last Updated