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)
Facility
City
Region
Status
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
More Janssen Research & Development, LLC trials in Australia
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.
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