Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell, Diffuse
Investigational drug(s) / intervention(s)
JNJ-90014496
JNJ-90014496: JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
Study summary
This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability] — Up to 15 Years post JNJ-90014496 infusion Occurrence of any AEs, including dose limiting toxicities (DLTs).
Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC) — Up to 6 months post last participant's JNJ-90014496 infusion Overall response is defined as a PR or CR at any point between the time of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
Trial sites (32)
Facility
City
Region
Status
City of Hope
Duarte
California
Colorado Blood Cancer Institute
Denver
Colorado
University of Iowa Hospital and Clinics
Iowa City
Iowa
University of Kentucky Medical Center
Lexington
Kentucky
Rutgers Cancer Institute of New Jersey
Piscataway
New Jersey
Levine Cancer Institute
Charlotte
North Carolina
University Hospitals Cleveland Medical Center
Cleveland
Ohio
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Greco Hainesworth Tennessee Oncology Centers for Research
Nashville
Tennessee
Sarah Cannon Research Institute
Nashville
Tennessee
St. David's South Austin Medical Center
Austin
Texas
MD Anderson Cancer Center
Houston
Texas
Texas Transplant Institute
San Antonio
Texas
Swedish Cancer Institute
Seattle
Washington
St Vincents Hospital Melbourne
Fitzroy
Australia
The Alfred Hospital
Melbourne
Australia
Fiona Stanley Hospital
Murdoch
Australia
Calvary Mater Newcastle Hospital
Waratah
Australia
Princess Margaret Cancer Centre University Health Network
Toronto
Ontario
Rigshospitalet
Copenhagen
Denmark
Odense University Hospital
Odense
Denmark
Erasmus MC
Rotterdam
Netherlands
UMC Utrecht
Utrecht
Netherlands
Seoul National University Hospital
Seoul
South Korea
Asan Medical Center
Seoul
South Korea
Samsung Medical Center
Seoul
South Korea
Hosp Univ Vall D Hebron
Barcelona
Spain
Hosp Clinic de Barcelona
Barcelona
Spain
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona
Spain
Hosp Univ Fund Jimenez Diaz
Madrid
Spain
University College London Hospitals
London
United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester
United Kingdom
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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