Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05421663

A Study of JNJ-90014496 in 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St Vincents Hospital Melbourne, Fitzroy, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prizloncabtagene autoleucel (Prizlo-Cel)

Biological

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. Phase 1b: Pharmacokinetic Evaluation of Prizlo-Cel

    Time frame: Up to 2 Years post prizlo-cel infusion

    Prizlo-cel blood levels will be reported.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2028
Study completion
2041
First posted
Jun 16, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.