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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
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

Full criteria on ClinicalTrials.gov

Sites (52)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Vienna
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ViennaAustriaCompleted
-
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MontrealCanadaUnknown status
-
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TorontoCanadaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Staedtisches Klinikum Karlsruhe gGmbH
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KarlsruheGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
-
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LondonUnited KingdomUnknown status
-
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ManchesterUnited KingdomUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Istituto Nazionale dei Tumori,
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NaplesItalyActive, not recruiting
-
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Chuo-kuJapanUnknown status
-
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FukuokaJapanUnknown status
-
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Minato-kuJapanUnknown status
-
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SapporoJapanUnknown status
Karolinska University Hospital
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HuddingeSwedenActive, not recruiting
-
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AuroraUnited StatesUnknown status
-
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BaltimoreUnited StatesUnknown status
-
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BostonUnited StatesUnknown status
-
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BostonUnited StatesUnknown status
-
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CharlotteUnited StatesUnknown status
-
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CharlottesvilleUnited StatesUnknown status
-
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ChicagoUnited StatesUnknown status
-
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ClevelandUnited StatesUnknown status
-
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DallasUnited StatesUnknown status
-
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DetroitUnited StatesUnknown status
-
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HoustonUnited StatesUnknown status
-
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HoustonUnited StatesUnknown status
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Iowa CityUnited StatesUnknown status
-
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MorristownUnited StatesUnknown status
-
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New HavenUnited StatesUnknown status
-
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New YorkUnited StatesUnknown status
-
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NilesUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
-
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PortlandUnited StatesUnknown status
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Santa MonicaUnited StatesUnknown status
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SeattleUnited StatesUnknown status
-
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Sioux FallsUnited StatesUnknown status
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WichitaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.