Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT03484702
Last Updated: 2024-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2018-06-05
2023-12-15
Brief Summary
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Detailed Description
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Once enrolled, participants will undergo leukapheresis to enable JCAR017 cell product generation. Upon successful JCAR017 cell product generation, participants will receive lymphodepleting chemotherapy followed by infusion of JCAR017. JCAR017 will be administered by intravenous infusion. Participants 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of JCAR017
JCAR017
Specified dose on specified days
Interventions
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JCAR017
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ function
* Adequate vascular access for leukapheresis procedure
Exclusion Criteria
* Received previous CD19-targeted therapy
* Progressive vascular tumor invasion, thrombosis, or embolism
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 101
Vienna, , Austria
Local Institution - 351
Ghent, , Belgium
Local Institution - 551
Helsinki, , Finland
Local Institution - 202
Lille, , France
Local Institution - 203
Paris, , France
Local Institution - 201
Pierre-Bénite, , France
Local Institution - 151
Cologne, , Germany
Local Institution - 152
Dresden, , Germany
Local Institution - 155
Heidelberg, , Germany
Local Institution - 154
München, , Germany
Local Institution - 153
Ulm, , Germany
Local Institution - 402
Milan, , Italy
Local Institution - 401
Torino, , Italy
Local Institution - 601
Chuo-ku, Tokyo, Japan
Local Institution - 602
Minato-ku, Tokyo, Japan
Local Institution - 301
Rotterdam, , Netherlands
Local Institution - 451
Barcelona, , Spain
Local Institution - 251
Bern, , Switzerland
Local Institution - 502
Manchester, Lancashire, United Kingdom
Local Institution - 501
London, , United Kingdom
Countries
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References
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Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1209-4055
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017-000106-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JCAR017-BCM-001
Identifier Type: -
Identifier Source: org_study_id