Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
Prizloncabtagene autoleucel (Prizlo-Cel)
JNJ-90014496
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be greater than or equal to (>=) 18 years of age, at the time ofsigning informed consent
Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20positive
Must meet the indications for each subtype in Phase 1b as specified in protocol andPhase 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 diseasedefined as 1 or more of the following: Stable disease or Progressive disease (PD) asbest response to most recent anti-lymphoma therapy OR disease progression orrecurrence after a partial response (PR) or complete response (CR) to most recentanti 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
Exclusion Criteria:
History of symptomatic deep vein thrombosis or pulmonary embolism within six monthsof apheresis (line associated deep vein thrombosis is allowed)
History of stroke, unstable angina, myocardial infarction, congestive heart failureNew York Heart Association (NYHA) Class III or IV, severe cardiomyopathy orventricular arrhythmia requiring medication or mechanical control within 6 months ofapheresis
History of a seizure disorder, dementia, cerebellar disease or neurodegenerativedisorder
Known history or prior diagnosis of optic neuritis or other immunologic orinflammatory disease affecting the central nervous system
Current active liver or biliary disease (except for Gilbert's syndrome orasymptomatic gallstones)
Evidence of active viral or bacterial infection requiring systemic antimicrobialtherapy, or uncontrolled systemic fungal infection
Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-richlarge B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoidgranulomatosis 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 celltherapy within 12 weeks of apheresis
Study Design
Connect with a study center
St Vincents Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy 2166584, 3065
AustraliaSite Not Available
The Alfred Hospital
Melbourne, 3004
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne 2158177, 3004
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, 6150
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch 8349091, 6150
AustraliaSite Not Available
Calvary Mater Newcastle Hospital
Waratah, 2298
AustraliaCompleted
Calvary Mater Newcastle Hospital
Waratah 10103871, 2298
AustraliaSite Not Available
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario M5G2M9
CanadaActive - Recruiting
Princess Margaret Cancer Centre University Health Network
Toronto 6167865, Ontario 6093943 M5G2M9
CanadaSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkSite Not Available
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
Odense University Hospital
Odense 2615876, 5000
DenmarkSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Erasmus MC
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Erasmus MC
Rotterdam 2747891, 3015 GD
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3584 CX
NetherlandsActive - Recruiting
UMC Utrecht
Utrecht 2745912, 3584 CX
NetherlandsSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Hosp Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, 08908
SpainActive - Recruiting
Hosp Clinic de Barcelona
Barcelona 3128760, 08036
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona 3128760, 08908
SpainSite Not Available
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid 3117735, 28040
SpainSite Not Available
University College London Hospitals
London, NW1 2BU
United KingdomActive - Recruiting
University College London Hospitals
London 2643743, NW1 2BU
United KingdomSite Not Available
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie NHS Foundation Trust Christie Hospital
Manchester 2643123, M20 4BX
United KingdomSite Not Available
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Medical Center
Duarte, California 91010-3000
United StatesActive - Recruiting
City of Hope
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospital and Clinics
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesActive - Recruiting
University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey 08854
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
Piscataway 5102713, New Jersey 5101760 08854
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28001
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28001
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesSite Not Available
Greco Hainesworth Tennessee Oncology Centers for Research
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Greco Hainesworth Tennessee Oncology Centers for Research
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
St. David's South Austin Medical Center
Austin, Texas 78704
United StatesActive - Recruiting
Texas Transplant Institute
San Antonio, Texas 78229
United StatesActive - Recruiting
St. David's South Austin Medical Center
Austin 4671654, Texas 4736286 78704
United StatesSite Not Available
Texas Transplant Institute
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
VCU Medical Center
Richmond 4781708, Virginia 6254928 23219
United StatesSite Not Available
Swedish Cancer Institute
Seattle, Washington 98104
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available

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