Trial Title:
A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
NCT ID:
NCT05784441
Condition:
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-90009530
Description:
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Arm group label:
JNJ-90009530
Other name:
C-CAR066
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 safe 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?
Detailed description:
This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous
anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy,
for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin
lymphoma (r/r B-NHL).
This trial will employ the Bayesian optimal interval (BOIN) design to determine the
recommended Phase 2 dose (RP2D).
Criteria for 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, cerebrovascular ischemia/hemorrhage, 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Iowa Hospital
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40506
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers University
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Royal Prince Alfred Hospital
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Royal Brisbane and Women's Hospital
Address:
City:
Herston
Zip:
4029
Country:
Australia
Status:
Recruiting
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
5266202
Country:
Israel
Status:
Recruiting
Facility:
Name:
University College London Hospitals
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Status:
Recruiting
Start date:
November 6, 2023
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05784441
