A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
City of Hope
RECRUITING
Duarte
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Iowa
University of Iowa Hospital and Clinics
RECRUITING
Iowa City
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
Piscataway
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
Greco Hainesworth Tennessee Oncology Centers for Research
RECRUITING
Nashville
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
St. David's South Austin Medical Center
RECRUITING
Austin
MD Anderson Cancer Center
RECRUITING
Houston
Texas Transplant Institute
RECRUITING
San Antonio
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Other Locations
Australia
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Calvary Mater Newcastle Hospital
COMPLETED
Waratah
Canada
Princess Margaret Cancer Centre University Health Network
RECRUITING
Toronto
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Netherlands
Erasmus MC
RECRUITING
Rotterdam
UMC Utrecht
RECRUITING
Utrecht
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
ICO L'Hospitalet - Hospital Duran i Reynals
RECRUITING
Barcelona
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
United Kingdom
University College London Hospitals
RECRUITING
London
The Christie NHS Foundation Trust Christie Hospital
RECRUITING
Manchester
Contact Information
Primary
Study Contact, M.D.
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2022-08-12
Estimated Completion Date:2029-03-29
Participants
Target number of participants:439
Treatments
Experimental: Prizlo-Cel
Participants will receive intravenous (IV) infusion of autologous prizlo-cel.