Clinical trial NCT05784441: A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Calculate the Occurence of Adverse Events
timeFrame: up to 24 months
measure: Determine Recommended Phase 2 dose (RP2D)
timeFrame: up to 24 months
Secondary outcomes:
measure: Determine the Overall Response (OR)
timeFrame: up to 24 months
measure: Determine the time to response (TTR)
timeFrame: up to 24 months
measure: Determine the duration of response (DOR)
timeFrame: up to 24 months
measure: Measure the amount of JNJ-90009530 in blood over time
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: