🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04245839
Active, not recruiting Phase 2

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839 · tracked via the Priya Life Science UK tracker
Sponsor
Celgene
Phase
Phase 2
Started
2020-07-14
Last updated
2025-11-05

Condition(s) studied

Lymphoma, Non-Hodgkin

Investigational drug(s) / intervention(s)

FludarabineCyclophosphamideJCAR017

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 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 prior line of systemic therapy are eligible if they present with high risk features. Patients that received two 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) or relapsed after hematopoietic stem cell transplant 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function 7. Adequate vascular access for leukapheresis procedure Exclusion Criteria: 1. Evidence or history 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 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 13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
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 UK

Other trials for the same condition

Official registry record

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 UK