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

July 2, 2026 updated by: Janssen Research & Development, LLC

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • St Vincents Hospital Melbourne
      • Melbourne, Australia, 3004
        • The Alfred Hospital
      • Murdoch, Australia, 6150
        • Fiona Stanley Hospital
      • Waratah, Australia, 2298
        • Calvary Mater Newcastle Hospital
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • Princess Margaret Cancer Centre University Health Network
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08908
        • ICO L'Hospitalet - Hospital Duran i Reynals
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28040
        • Hosp Univ Fund Jimenez Diaz
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College London Hospitals
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust Christie Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers Cancer Institute of New Jersey
    • North Carolina
      • Charlotte, North Carolina, United States, 28001
        • Levine Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University hospitals cleveland medical center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Greco Hainesworth Tennessee Oncology Centers for Research
    • Texas
      • Austin, Texas, United States, 78704
        • St. David's South Austin Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prizlo-Cel
Participants will receive intravenous (IV) infusion of autologous prizlo-cel.
Biological: Prizloncabtagene autoleucel (Prizlo-Cel)
Prizlo-Cel, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
Other Names:
  • JNJ-90014496

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
Time Frame: Up to 2 Years post prizlo-cel infusion
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)
Time Frame: Up to 2 Years post prizlo-cel infusion
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score
Time Frame: From Baseline Up to 18 months
The FACT-Lym was developed for adult patients with lymphoma. The FACT Lym is self-administered, with a recall period for all items being the past 7 days. Responses are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very much". Higher scores indicate fewer symptoms and better well-being.
From Baseline Up to 18 months
Phase 1b: Overall Response (OR)
Time Frame: Up to 2 Years post prizlo-cel infusion
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
Phase 1b: Duration of Response (DOR)
Time Frame: Up to 2 Years post prizlo-cel infusion
DOR is defined as the time from the first documented CR or PR after prizlo-cel infusion until PD or death, whichever occurs first (per Lugano 2014 guidelines).
Up to 2 Years post prizlo-cel infusion
Phase 1b: Pharmacokinetic Evaluation of Prizlo-Cel
Time Frame: Up to 2 Years post prizlo-cel infusion
Prizlo-cel blood levels will be reported.
Up to 2 Years post prizlo-cel infusion
Phase 2: Occurrence of Adverse Events (AEs) by Severity
Time Frame: Up to 2 Years post prizlo-cel infusion
Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening ), Grade 5 (Death). Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICANS), and Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Up to 2 Years post prizlo-cel infusion
Phase 2: Complete Response (CR)
Time Frame: Up to 2 Years post prizlo-cel infusion
A CR is defined as at any point between the date of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first.
Up to 2 Years post prizlo-cel infusion
Phase 2: Duration of Response (DOR)
Time Frame: Up to 2 Years post prizlo-cel infusion
DOR is defined as the time from the first documented CR or PR after prizlo-cel infusion to relapse or death, whichever occurs first.
Up to 2 Years post prizlo-cel infusion
Phase 2: Progression Free Survival (PFS)
Time Frame: Up to 2 Years post prizlo-cel infusion
PFS is defined as the time from the date of prizlo-cel infusion to the date of first documented disease progression, or death due to any cause, whichever occurs first.
Up to 2 Years post prizlo-cel infusion
Phase 2: Overall Survival (OS)
Time Frame: Up to 2 Years post prizlo-cel infusion
OS is defined as the time from the date of prizlo-cel infusion to the date of death due to any cause.
Up to 2 Years post prizlo-cel infusion
Phase 2: Maximum Observed Blood Concentration (Cmax) for Prizlo-Cel
Time Frame: Up to 2 Years post prizlo-cel infusion
Blood samples will be analyzed to report Cmax for prizlo-cel.
Up to 2 Years post prizlo-cel infusion
Phase 2: Time to Reach Maximum Observed Cmax (Tmax) for Prizlo-Cel
Time Frame: Up to 2 Years post prizlo-cel infusion
Blood samples will be analyzed to report Tmax for prizlo-cel.
Up to 2 Years post prizlo-cel infusion
Phase 2: Area Under the Blood Concentration Time Curve (AUC) for Prizlo-Cel
Time Frame: Up to 2 Years post prizlo-cel infusion
AUC for prizlo-cel will be reported.
Up to 2 Years post prizlo-cel infusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Throughout the first 12 months follow up period completion (3 years)
The time from the date of C-CAR039 infusion to the date of first documented disease progression or death
Throughout the first 12 months follow up period completion (3 years)
Overall survival (OS)
Time Frame: Throughout the first 12 months follow up period completion (3 years)
The time from the date of C-CAR039 infusion to the date of death
Throughout the first 12 months follow up period completion (3 years)
The B cell percentage changes and CD19/CD20 expression changes in blood
Time Frame: up to 24 months
The B cell percentage changes and CD19/CD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion;
up to 24 months
Blood cytokines changes
Time Frame: up to 24 months
Blood cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) changes over time in blood
up to 24 months
Anti-drug (C-CAR039) antibody
Time Frame: Up to 24 months
Presence of serum anti-drug (C-CAR039) antibody
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
City of Hope Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2041

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90014496LYM1001 (Janssen Research & Development, LLC)
  • 2023-506267-33-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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