A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prizloncabtagene autoleucel (Prizlo-Cel)
Treatment groups
439 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov