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?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
University of Iowa Hospital
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Calculate the Occurence of Adverse Events
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
Time frame: up to 24 months
Determine Recommended Phase 2 dose (RP2D)
Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities
Time frame: up to 24 months
Determine the Overall Response (OR)
Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014
Time frame: up to 24 months
Determine the time to response (TTR)
Record the number of days from the date of JNJ-90009530 infusion to a CR or PR
Time frame: up to 24 months
Determine the duration of response (DOR)
Record the number of days from the date of the first CR or PR to relapse or death.
Time frame: up to 24 months
Measure the amount of JNJ-90009530 in blood over time
Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).
Time frame: up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rutgers University
New Brunswick, New Jersey, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre
Clayton, Australia
Austin Hospital
Heidelberg, Australia
...and 5 more locations