A Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific 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-90014496 and to determine the recommended Phase 2 dose(s) (RP2D[s]).
The secondary objectives are to evaluate the preliminary efficacy of JNJ-90014496 in participants with r/r B-NHL and to characterize JNJ-90014496 PK in blood.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Joanna Rhodes MD
- Principal Investigator
- Participant must be greater than or equal to (>=) 18 years of age, at the time of
signing informed consent
- Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular
lymphoma
- Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20
positive
- Must have relapsed or refractory disease with the following indications for each
histologic subtype: Mature aggressive large B cell non-Hodgkin lymphoma (NHL) and
follicular lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy,
or >= 1 line of systemic therapy for participants who are ineligible for autologous
stem cell transplant; 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
- Measurable disease as defined by Lugano 2014 classification
- Eastern cooperative oncology group (ECOG) performance status of either 0 or 1
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
- 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.