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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Prizloncabtagene autoleucel (Prizlo-Cel)
Biological/VaccinePrizlo-Cel, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
Treatment groups
439 Participants
are divided into 1 treatment groupGroup A: Prizlo-CelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
Occurrence of any AEs, including dose limiting toxicities (DLTs).
Time frame
Up to 2 Years post prizlo-cel infusion2
Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)
Overall response is defined as a PR or CR at any point between the time of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Time frame
Up to 2 Years post prizlo-cel infusionSecondary outcomes
1
Phase 1b: Overall Response (OR)
Overall response is defined as a PR or CR at any point between the time of prizlo-cel infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Time frame
Up to 2 Years post prizlo-cel infusion2
Phase 1b: Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR after prizlo-cel infusion until PD or death, whichever occurs first (per Lugano 2014 guidelines).
Time frame
Up to 2 Years post prizlo-cel infusion3
Phase 1b: Pharmacokinetic Evaluation of Prizlo-Cel
Prizlo-cel blood levels will be reported.
Time frame
Up to 2 Years post prizlo-cel infusion4
Phase 2: Occurrence of Adverse Events (AEs) by Severity
Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening ), Grade 5 (Death). Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICANS), and Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Time frame
Up to 2 Years post prizlo-cel infusionSponsors and contacts
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Source ClinicalTrials.gov