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 University
Inclusion Criteria: - Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent - Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive - Must meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocol - Measurable disease as defined by Lugano 2014 classification - Eastern cooperative oncology group (ECOG) performance status of 0 to 2 Exclusion Criteria: - History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed) - 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 apheresis - 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 - Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones) - Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection - Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's Macroglobulinemia - Any prior solid organ or allogeneic stem cell transplantation - Autologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis
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.