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
The primary objectives are to assess the safety and tolerability of JNJ-90009530 and to determine the
recommended Phase 2 dose(s)(RP2D[s]). Secondary objectives are to evaluate the preliminary efficacy of
JNJ-90009530 in participants with r/r B-NHL and to characterize JNJ-90009530 pharmacokinetics (PK) in blood.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Matthew Matasar
- Principal Investigator
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)
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.