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

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: Recruiting
• Conditions: Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
• Intervention / Treatment: Biological: Prizloncabtagene autoleucel (Prizlo-Cel)

• Study Type: Interventional
• Enrollment (Estimated): 439
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact, M.D.; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score	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)	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)	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	Prizlo-cel blood levels will be reported.	Up to 2 Years post prizlo-cel infusion
Phase 2: Occurrence of Adverse Events (AEs) by Severity	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)	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)	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)	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)	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	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	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	AUC for prizlo-cel will be reported.	Up to 2 Years post prizlo-cel infusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	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)	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	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	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	Presence of serum anti-drug (C-CAR039) antibody	Up to 24 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Collaborators: City of Hope Medical Center
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): March 12, 2029

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CD20/CD19
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin
• Other Study ID 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