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NCT Number: NCT05784441

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

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 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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Prince Alfred Hospital, Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key 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

Key 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, 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)

Treatment and study plan

JNJ-90009530

Drug

JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20

Other names: C-CAR066

Primary outcomes

  1. Calculate the Occurence of Adverse Events

    Time frame: up to 24 months

    The 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 5.0

  2. Determine Recommended Phase 2 dose (RP2D)

    Time frame: up to 24 months

    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities

Secondary outcomes

  1. Determine the Overall Response (OR)

    Time frame: up to 24 months

    Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014

  2. Determine the time to response (TTR)

    Time frame: up to 24 months

    Record the number of days from the date of JNJ-90009530 infusion to a CR or PR

  3. Determine the duration of response (DOR)

    Time frame: up to 24 months

    Record the number of days from the date of the first CR or PR to relapse or death.

  4. Measure the amount of JNJ-90009530 in blood over time

    Time frame: up to 24 months

    Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Important dates

Study start
2023
Primary completion
2027
Study completion
2040
First posted
Mar 24, 2023
Registry last updated
Jun 5, 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.

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