Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 1

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

NCT05784441 · tracked via the Priya Life Science Israel tracker
Phase
Phase 1
Started
2023-11-06
Last updated
2026-09-25

Condition(s) studied

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

JNJ-90009530

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

Study summary

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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Calculate the Occurence of Adverse Events — 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
  • Determine Recommended Phase 2 dose (RP2D) — up to 24 months
    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities

Trial sites (15)

FacilityCityRegionStatus
University of Iowa Hospital Iowa City Iowa
University of Kentucky Lexington Kentucky
Mayo Clinic Rochester Rochester Minnesota
Rutgers University New Brunswick New Jersey
University Hospitals Cleveland Medical Center Cleveland Ohio
University of Pennsylvania Philadelphia Pennsylvania
MD Anderson Cancer Center Houston Texas
Royal Prince Alfred Hospital Camperdown Australia
Monash Medical Centre Clayton Australia
Austin Hospital Heidelberg Australia
Royal Brisbane and Women's Hospital Herston Australia
Westmead Hospital Westmead Australia
Hadassah Medical Center Jerusalem Israel
Sheba Medical Center Ramat Gan Israel
University College London Hospitals London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05784441 on ClinicalTrials.gov ↗ ← All trials in Israel