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Recruiting Phase 1/2 NCT05421663

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Phase 1/2 – combined early trial
Conditions: Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

Sponsor: Janssen Research & Development, LLC

trial.available_in: БГ
Overview
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).
Who can participate
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
Locations 8
Australia (1)
St Vincents Hospital Melbourne
Fitzroy
Canada (1)
Princess Margaret Cancer Centre University Health Network
Toronto , Ontario
Denmark (1)
Rigshospitalet
Copenhagen
Netherlands (1)
Erasmus MC
Rotterdam
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Hosp Univ Vall D Hebron
Barcelona
United Kingdom (1)
University College London Hospitals
London
United States (1)
City of Hope
Duarte , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.08.2022
Completion date
29.03.2029
Registry ID
NCT05421663
Source
anzctr
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