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Purpose

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?

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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, 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)

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-90009530
  • Drug: JNJ-90009530
    JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
    Other names:
    • C-CAR066

Recruiting Locations

University of Iowa Hospital
Iowa City 4862034, Iowa 4862182 52242

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506

Rutgers University
New Brunswick 5101717, New Jersey 5101760 08901

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.