A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Condition(s) studied
Investigational drug(s) / intervention(s)
Fludarabine: Fludarabine
Cyclophosphamide: Cyclophosphamide
JCAR017: JCAR017
Study 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 5 years.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) — Up to 60 months
Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 111 | Santa Monica | California | |
| Local Institution - 107 | Aurora | Colorado | |
| Local Institution - 105 | New Haven | Connecticut | |
| Local Institution - 103 | Chicago | Illinois | |
| Local Institution - 109 | Niles | Illinois | |
| Local Institution - 122 | Iowa City | Iowa | |
| Local Institution - 124 | Wichita | Kansas | |
| Local Institution - 102 | Baltimore | Maryland | |
| Local Institution - 100 | Boston | Massachusetts | |
| Local Institution - 101 | Boston | Massachusetts | |
| Local Institution - 127 | Detroit | Michigan | |
| Local Institution - 123 | Morristown | New Jersey | |
| Local Institution - 116 | New York | New York | |
| Local Institution - 110 | Charlotte | North Carolina | |
| Local Institution - 112 | Cleveland | Ohio | |
| Local Institution - 114 | Portland | Oregon | |
| Local Institution - 117 | Philadelphia | Pennsylvania | |
| Local Institution - 113 | Sioux Falls | South Dakota | |
| Local Institution - 121 | Dallas | Texas | |
| Local Institution - 104 | Houston | Texas | |
| Local Institution - 119 | Houston | Texas | |
| Local Institution - 115 | Charlottesville | Virginia | |
| Local Institution - 108 | Seattle | Washington | |
| Local Institution - 450 | Vienna | Austria | |
| Local Institution - 150 | Toronto | Ontario | |
| Local Institution - 151 | Montreal | Quebec | |
| Local Institution - 252 | Lille | France | |
| Local Institution - 251 | Montpellier | France | |
| Local Institution - 255 | Paris | France | |
| Local Institution - 250 | Pierre-Bénite | France | |
| Local Institution - 253 | Rennes | France | |
| Local Institution - 254 | Toulouse | France | |
| Local Institution - 500 | Ulm | Baden-Wurttemberg | |
| Local Institution - 504 | Regensburg | Bavaria | |
| Local Institution - 501 | Cologne | Germany | |
| Local Institution - 503 | Karlsruhe | Germany | |
| Local Institution - 502 | Munich | Germany | |
| Local Institution - 300 | Bergamo | Italy | |
| Local Institution - 301 | Naples | Italy | |
| Local Institution - 553 | Sapporo | Hokkaido |
+ 9 more sites — see the full list on the official registry below.
More Celgene trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04245839 on ClinicalTrials.gov ↗ ← All trials in the USA