A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

JNJ-90014496

Clinical Study ID

NCT05421663
90014496LYM1001
2023-506267-33
90014496LYM1001
2023-506267-33-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be greater than or equal to (>=) 18 years of age, at the time ofsigning informed consent

  • Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20positive

  • Must meet the following indications for each subtype: Relapsed or refractory matureaggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b:Participants must have had >= 2 lines of systemic therapy or >= 1 line of systemictherapy in case of participants ineligible for high-dose chemotherapy and autologoushematopoietic stem cell transplantation (HSCT); Relapsed or refractory follicularlymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had >= 2prior lines of anti-neoplastic systemic therapy. Participants also must have priorexposure to an anti-CD20 monoclonal antibody

  • Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must haveDLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positiveinterim positron emission computed tomography 2 or 3 cycles of frontlinechemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontlinechemoimmunotherapy for DLBCL

  • Measurable disease as defined by Lugano 2014 classification

  • Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOGof 0 to 2 is allowed in frontline high-risk DLBCL cohort

Exclusion

Exclusion Criteria:

  • Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-richlarge B-cell lymphoma

  • Any prior solid organ or allogeneic stem cell transplantation

  • Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) Tcell infusion

  • Uncontrolled active infections

  • History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])

  • History of stroke, unstable angina, myocardial infarction, congestive heart failureNew York Heart Association (NYHA) Class III or IV, severe cardiomyopathy orventricular arrhythmia requiring medication or mechanical control within 6 months ofscreening

  • History of a seizure disorder, dementia, cerebellar disease or neurodegenerativedisorder

  • Known history or prior diagnosis of optic neuritis or other immunologic orinflammatory disease affecting the central nervous system

  • Current active liver or biliary disease (except for Gilbert's syndrome orasymptomatic gallstones)

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: JNJ-90014496
Phase: 1
Study Start date:
August 12, 2022
Estimated Completion Date:
December 29, 2028

Connect with a study center

  • St Vincents Hospital Melbourne

    Fitzroy, 3065
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, 3065
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, 2298
    Australia

    Active - Recruiting

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • ICO L'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • University College London Hospitals

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Medical Center

    Duarte, California 91010-3000
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    Piscataway, New Jersey 08854
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28001
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • St. David's South Austin Medical Center

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

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