A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
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
2 other identifiers
interventional
439
8 countries
32
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 16, 2022
CompletedStudy Start
First participant enrolled
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2029
April 13, 2026
April 1, 2026
6.4 years
June 10, 2022
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
Occurrence of any AEs, including dose limiting toxicities (DLTs).
Up to 2 Years post prizlo-cel infusion
Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)
Overall response is defined as a PR or CR at any point between the time of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Up to 2 Years post prizlo-cel infusion
Secondary Outcomes (12)
Phase 1b: Overall Response (OR)
Up to 2 Years post prizlo-cel infusion
Phase 1b: Duration of Response (DOR)
Up to 2 Years post prizlo-cel infusion
Phase 1b: Pharmacokinetic Evaluation of Prizlo-Cel
Up to 2 Years post prizlo-cel infusion
Phase 2: Occurrence of Adverse Events (AEs) by Severity
Up to 2 Years post prizlo-cel infusion
Phase 2: Complete Response (CR)
Up to 2 Years post prizlo-cel infusion
- +7 more secondary outcomes
Study Arms (1)
Prizlo-Cel
EXPERIMENTALParticipants will receive intravenous (IV) infusion of autologous prizlo-cel.
Interventions
Prizlo-Cel, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
City of Hope
Duarte, California, 91010, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, 08854, United States
Levine Cancer Institute
Charlotte, North Carolina, 28001, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Greco Hainesworth Tennessee Oncology Centers for Research
Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
St. David's South Austin Medical Center
Austin, Texas, 78704, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Calvary Mater Newcastle Hospital
Waratah, 2298, Australia
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G2M9, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense, 5000, Denmark
Erasmus MC
Rotterdam, 3015 GD, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
University College London Hospitals
London, NW1 2BU, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 16, 2022
Study Start
August 12, 2022
Primary Completion (Estimated)
December 29, 2028
Study Completion (Estimated)
March 29, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.