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This open-label Phase 2 study will evaluate the safety and efficacy of modified T cells (JCAR017) administered to adult patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The study will also help determine how long the modified T cells stay in the patient's body. Furthermore, changes in the patient's quality of life will be described. Phase 2 (autologous T cells expressing anti-CD19 chimeric antigen receptor) (DLBCL NOS [de novo or tFL], follicular lymphoma Grade 3B [FL3B], high grade B-cell Lymphoma [HGBL] and primary central nervous system lymphoma [PCNSL]).
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03484702 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Claudia Schusterbauer, MD |
Principal Investigator Affiliation | Celgene Corporation |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Belgium, Finland, France, Germany, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lymphoma, Non-Hodgkin |
This is a single-arm, multi-cohort, multi-center, Phase 2 study to determine the efficacy and safety of JCAR017 in adult patients with aggressive B-cell NHL. The study will enroll patients in Europe and Japan with diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (HGBL), follicular lymphoma Grade 3B (FL3B), and primary central nervous system lymphoma (PCNSL). Patients with secondary central nervous system (CNS) involvement are allowed. Once enrolled, patients will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, patients will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells by intravenous infusion. Patients will be followed for approximately 2 years after their JCAR017 infusion for safety, disease status, survival and health-related quality of life. Delayed adverse events following exposure to gene modified T cells will be assessed and long-term persistence of these modified T cells will continue to be monitored under a separate long-term follow-up protocol for up to 15 years after JCAR017 infusion as per competent authority guidelines.
Experimental: Administration of JCAR017
JCAR017 will be infused at a dose of 100 x 10^6 JCAR017-positive transfected viable T cells (50 × 10^6 CD8+ CAR+ T cells and 50 × 10^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of lymphodepleting chemotherapy (LD) chemotherapy)
Drug: - JCAR017
JCAR017
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
Wien, , 1090
Status
Recruiting
Address
Universitair Ziekenhuis Gent
Gent, , 9000
Status
Recruiting
Address
Helsinki University
Helsinki, , 00029
Status
Recruiting
Address
CHRU-Hopital Claude Huriez
Lille, , 59037
Status
Recruiting
Address
Hopital Saint Louis
Paris Cedex 10, , 75475
Status
Recruiting
Address
Centre Hospitalier Lyon Sud
Pierre Benite cedex, , 69495
Status
Recruiting
Address
Medizinische Kinik und Poliklinik I
Dresden, , 01307
Status
Recruiting
Address
Universitaetsklinikum Heidelberg
Heidelberg, , 69120
Status
Recruiting
Address
Universitat zu Koln
Köln, , 50937
Status
Recruiting
Address
LMU Klinikum der Universität
München, , 81377
Status
Recruiting
Address
Universitatsklinikum Ulm
Ulm, , 89081
Status
Recruiting
Address
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , 20133
Status
Recruiting
Address
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, , 10126
Status
Recruiting
Address
National Cancer Center Hospital
Chuo-ku, , 104-0045
Status
Recruiting
Address
Toranomon Hospital
Minato-ku, , 105-8470
Status
Recruiting
Address
Erasmus Medisch Centrum
Rotterdam, , 3015 CE
Status
Recruiting
Address
Hospital Val d'Hebron
Barcelona, , 08035
Status
Recruiting
Address
Universitatsspital Bern
Bern, , 3010
Status
Recruiting
Address
UCL Cancer Institute
London, , WC1E 6BT
Status
Recruiting
Address
The Christie NHS Foundation Trust
Manchester, , M20 4BX