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A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
Trial Status: active
This is a Phase 1b/2, multicenter, open-label, study of prizloncabtagene autoleucel
(prizlo-cel), an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy
targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult
participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or
frontline high-risk diffuse large B-cell lymphoma (DLBCL).
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05421663.
