A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
NCT ID: NCT04245839
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
276 participants
INTERVENTIONAL
2020-07-14
2031-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of JCAR017
* Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents.
* JCAR017 will be infused on Day 1 at a target dose of 100 × 10\^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Fludarabine
Fludarabine
Cyclophosphamide
Cyclophosphamide
JCAR017
JCAR017
Interventions
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Fludarabine
Fludarabine
Cyclophosphamide
Cyclophosphamide
JCAR017
JCAR017
Eligibility Criteria
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Inclusion Criteria
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
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
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 - 111
Santa Monica, California, United States
Local Institution - 107
Aurora, Colorado, United States
Local Institution - 105
New Haven, Connecticut, United States
Local Institution - 103
Chicago, Illinois, United States
Local Institution - 109
Niles, Illinois, United States
Local Institution - 122
Iowa City, Iowa, United States
Local Institution - 124
Wichita, Kansas, United States
Local Institution - 102
Baltimore, Maryland, United States
Local Institution - 100
Boston, Massachusetts, United States
Local Institution - 101
Boston, Massachusetts, United States
Local Institution - 127
Detroit, Michigan, United States
Local Institution - 123
Morristown, New Jersey, United States
Local Institution - 116
New York, New York, United States
Local Institution - 110
Charlotte, North Carolina, United States
Local Institution - 112
Cleveland, Ohio, United States
Local Institution - 114
Portland, Oregon, United States
Local Institution - 117
Philadelphia, Pennsylvania, United States
Local Institution - 113
Sioux Falls, South Dakota, United States
Local Institution - 121
Dallas, Texas, United States
Local Institution - 104
Houston, Texas, United States
Local Institution - 119
Houston, Texas, United States
Local Institution - 115
Charlottesville, Virginia, United States
Local Institution - 108
Seattle, Washington, United States
Local Institution - 450
Vienna, , Austria
Local Institution - 150
Toronto, Ontario, Canada
Local Institution - 151
Montreal, Quebec, Canada
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, Germany
Local Institution - 504
Regensburg, Bavaria, Germany
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, Japan
Local Institution - 550
Chuo-ku, Tokyo, Japan
Local Institution - 551
Minato-ku, Tokyo, Japan
Local Institution - 552
Fukuoka, , Japan
Local Institution - 353
Madrid, , Spain
Local Institution - 350
Salamanca, , Spain
Local Institution - 351
Seville, , Spain
Local Institution - 600
Stockholm, , Sweden
Local Institution - 200
London, , United Kingdom
Local Institution - 201
Manchester, , United Kingdom
Countries
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References
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Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jager U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024 Aug;30(8):2199-2207. doi: 10.1038/s41591-024-02986-9. Epub 2024 Jun 3.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1244-9768
Identifier Type: OTHER
Identifier Source: secondary_id
2024-510966-18
Identifier Type: OTHER
Identifier Source: secondary_id
JCAR017-FOL-001
Identifier Type: -
Identifier Source: org_study_id
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