Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Conditions
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?
Interventions
DRUGJNJ-90009530
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Overall Response (OR) | up to 24 months | Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014 |
| Determine the time to response (TTR) | up to 24 months | Record the number of days from the date of JNJ-90009530 infusion to a CR or PR |
| Determine the duration of response (DOR) | up to 24 months | Record the number of days from the date of the first CR or PR to relapse or death. |
| Measure the amount of JNJ-90009530 in blood over time | up to 24 months | Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR). |
Countries
Australia, Israel, United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed