A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT05421663
Last Updated: 2025-11-10
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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RECRUITING
PHASE1/PHASE2
385 participants
INTERVENTIONAL
2022-08-12
2028-12-29
Brief Summary
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Detailed Description
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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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JNJ-90014496
Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.
JNJ-90014496
JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)19 and CD20.
Interventions
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JNJ-90014496
JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)19 and CD20.
Eligibility Criteria
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Inclusion Criteria
* Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
* Must meet the following indications for each subtype in Phase 1b: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma (FL) Grade 3b: Participants must have had \>= 2 lines of systemic therapy or \>= 1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HSCT); Relapsed or refractory FL Grade 1-3a and marginal zone lymphoma: Participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody; Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography consistent with lymphoma after 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL; Phase 2 participants must have following: A diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy including an anthracycline containing chemotherapy regimen and an anti-CD20 monoclonal antibody; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; Cohort specific requirements:
Cohort A (CAR-T Naïve): participants who have previously not received CAR-T cell therapy for the treatment of lymphoma.
Cohort B (CAR-T Exposed): participants who have relapsed disease and prior exposure to CAR-T cell therapy for the treatment of lymphoma.
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of 0 to 2
Exclusion Criteria
* History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of apheresis
* History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
* Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
* Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
* Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
* Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and Burkitt-like lymphoma or Richter's transformation, Lymphomatoid granulomatosis, Plasmablastic lymphoma
* Any prior solid organ or allogeneic stem cell transplantation
* Autologous stem cell transplant within 12 weeks of apheresis; CAR-T exposed only: Prior CAR-T cell therapy within 12 weeks of apheresis
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
St Vincents Hospital Melbourne
Fitzroy, , Australia
The Alfred Hospital
Melbourne, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
Calvary Mater Newcastle Hospital
Waratah, , Australia
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Erasmus MC
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, , Spain
Hosp Univ Fund Jimenez Diaz
Madrid, , Spain
University College London Hospitals
London, , United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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90014496LYM1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506267-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
90014496LYM1001
Identifier Type: -
Identifier Source: org_study_id