NCT04245839Active, not recruitingPhase 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)
A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 27 Jan 2020
- Start date
- 14 Jul 2020
- Primary completion date
- 30 Sept 2031
- Lead sponsor
- Celgene
- Diseases
- Follicular lymphoma, Hodgkin lymphoma
- NCT number
- NCT04245839
- EU CT number
- 2024-510966-18-00
- EudraCT number
- 2019-004081-18
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 276
- From 14 Jul 2020 to the primary completion date, 30 Sept 2031
- 52 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CAR T-cell or other genetically-modified cell therapy
- Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis
Other illness
- Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
- Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
- History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
- History of or active human immunodeficiency virus (HIV)
- Active hepatitis B or active hepatitis C
- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
- Active autoimmune disease requiring immunosuppressive therapy
- Presence of acute or chronic graft-versus-host=disease
- History of significant cardiovascular disease
Other
- WHO subclassification of duodenal-type FL
- History or presence of clinically relevant central nervous system pathology
Who the study is looking for
- 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
- Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
- 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)
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Adequate vascular access for leukapheresis procedure
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Staedtisches Klinikum Karlsruhe gGmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Regensburg AöR Coordinator of this site? Confirm its status | Regensburg | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Istituto Nazionale dei Tumori, Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Niles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
Related publications
- Efficacy and safety of lisocabtagene maraleucel in adult Japanese patients with relapsed or refractory follicular lymphoma: 31-month follow-up of the phase 2 TRANSCEND FL study.Int J Clin Oncol · 2026 · PMID 42875607
- Durable efficacy and manageable long-term safety of lisocabtagene maraleucel for 3L+ FL: 3-year update from TRANSCEND FL.Blood · 2026 · PMID 42462111
This page is information, not medical advice. Discuss any trial with your doctor.