A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

PHASE1RECRUITING

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: * can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients. * will JNJ-90009530 help patients achieve a response and for how long?.

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Study details:

This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). This trial will employ the Bayesian optimal interval (BOIN) design to determine the recommended Phase 2 dose (RP2D).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
  • All participants must have relapsed or refractory disease for each histologic subtype
  • Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
  • Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
  • Tumor must be cluster of differentiation (CD) 20 positive
  • Measurable disease as defined by Lugano 2014 classification
  • Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1
  • Exclusion criteria

  • Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
  • Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
  • Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
  • Uncontrolled active infections
  • History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
  • 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 screening
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, 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
  • Active central nervous system (CNS) involvement by malignancy
  • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-11-06

    Primary completion: 2027-04-01

    Study completion finish: 2027-05-31

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05784441

    Intervention or treatment

    DRUG: JNJ-90009530

    Conditions

    • Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
    Image related to Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
    • Condition: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

    • DRUG: JNJ-90009530

    • Westmead, Not Specified, Australia and more

    • Sponsor: Janssen Research & Development, LLC

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    Select from list below to view details:

    • Westmead Hospital

      Westmead, Not Specified, Australia

    • Royal Prince Alfred Hospital

      Camperdown, Not Specified, Australia

    • Monash Medical Centre

      Clayton, Not Specified, Australia

    • Austin Hospital

      Heidelberg, Not Specified, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: JNJ-90009530
    • Not Specified
    DRUG: JNJ-90009530
    • JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Calculate the Occurence of Adverse EventsThe safety and tolerability will be measured by recording the occurence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0up to 24 months
    Determine Recommended Phase 2 dose (RP2D)Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicitiesup to 24 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Determine the Overall Response (OR)Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014up to 24 months
    Determine the time to response (TTR)Record the number of days from the date of JNJ-90009530 infusion to a CR or PRup to 24 months
    Determine the duration of response (DOR)Record the number of days from the date of the first CR or PR to relapse or death.up to 24 months
    Measure the amount of JNJ-90009530 in blood over timeReview pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).up to 24 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

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