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A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
NCT05421663 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma
About this study
This is a Phase 1b/2, multicenter, open-label, study of prizloncabtagene autoleucel (prizlo-cel), an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).
Eligibility criteria
Inclusion Criteria:
* Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent
* Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
* Must meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; 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 as mentioned in protocol
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of 0 to 2
Exclusion Criteria:
* History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
* 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 high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's Macroglobulinemia
* Any prior solid organ or allogeneic stem cell transplantation
* Autologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis
Study design
Enrollment target: 439 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-08-12
Estimated completion: 2029-03-29
Last updated: 2026-04-13
Interventions
Biological: Prizloncabtagene autoleucel (Prizlo-Cel)
Primary outcomes
- • Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability] (Up to 2 Years post prizlo-cel infusion)
- • Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC) (Up to 2 Years post prizlo-cel infusion)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact, M.D. · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (32)
City of HopeRecruiting
Duarte, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
University of Iowa Hospital and ClinicsRecruiting
Iowa City, Iowa, United States
University of Kentucky Medical CenterRecruiting
Lexington, Kentucky, United States
Rutgers Cancer Institute of New JerseyRecruiting
Piscataway, New Jersey, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Greco Hainesworth Tennessee Oncology Centers for ResearchRecruiting
Nashville, Tennessee, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
St. David's South Austin Medical CenterRecruiting
Austin, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Transplant InstituteRecruiting
San Antonio, Texas, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
St Vincents Hospital MelbourneRecruiting
Fitzroy, Australia
The Alfred HospitalRecruiting
Melbourne, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Australia
Calvary Mater Newcastle HospitalCompleted
Waratah, Australia
Princess Margaret Cancer Centre University Health NetworkRecruiting
Toronto, Ontario, Canada
RigshospitaletRecruiting
Copenhagen, Denmark
Odense University HospitalRecruiting
Odense, Denmark
Erasmus MCRecruiting
Rotterdam, Netherlands
UMC UtrechtRecruiting
Utrecht, Netherlands
Seoul National University HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp Clinic de BarcelonaRecruiting
Barcelona, Spain
ICO L'Hospitalet - Hospital Duran i ReynalsRecruiting
Barcelona, Spain
Hosp Univ Fund Jimenez DiazRecruiting
Madrid, Spain
University College London HospitalsRecruiting
London, United Kingdom
The Christie NHS Foundation Trust Christie HospitalRecruiting
Manchester, United Kingdom