Phase
Condition
Lymphoma, B-cell
Non-hodgkin's Lymphoma
Lymphoproliferative Disorders
Treatment
Glofitamab
Obinutuzumab
Tocilizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Depending upon study part, a history or status of: 1) a histologically-confirmedhematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatmentregimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [ASCT])
Measurable disease, defined as at least one bi-dimensionally measurable nodallesion, defined as > 1.5 cm in its longest dimension, or at least onebi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longestdimension
Able to provide a tumor tissue pretreatment biopsy at last relapse or duringscreening from a safely accessible site, per investigator determination, providingthe patient has more than one measurable target lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of >/=12 weeks
AEs from prior anti-cancer therapy must have resolved to Grade less than or equal to (
Adequate liver, hematological and renal function
Negative serologic or polymerase chain reaction (PCR) test results for acute orchronic Hepatitis B virus (HBV) infection
Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)
Negative serum pregnancy test within 7 days prior to study treatment in women ofchildbearing potential. Women who are not of childbearing potential who areconsidered to be post-menopausal (at least 12 months of non-therapy amenorrhea) orsurgically sterile (absence of ovaries and/or uterus) are not required to have apregnancy test
Exclusion
Exclusion Criteria:
Inability to comply with protocol mandated hospitalizations and restrictions
Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma andlymphoplasmacytic lymphoma
Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Participants with acute bacterial, viral, or fungal infection at baseline, confirmedby a positive blood culture within 72 hours prior to obinutuzumab infusion or byclinical judgment in the absence of a positive blood culture
Participants with known active infection, or reactivation of a latent infection,whether bacterial, viral, fungal, mycobacterial, or other pathogens or any majorepisode of infection requiring hospitalization or treatment with IV antibioticswithin 4 weeks of dosing
Prior treatment with systemic immunotherapeutic agents, including, but not limitedto, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines andmonoclonal antibodies (e.g., anti-cytotoxic T-lymphocyte-associated protein 4 [anti-CTLA4], anti-programmed death 1 [anti-PD1] and anti-programmed death ligand 1 [anti-PDL1]) within 4 weeks or five half-lives of the drug, whichever is shorter,before obinutuzumab infusion on Cycle 1 Day -7
History of treatment-emergent immune-related AEs associated with priorimmunotherapeutic agents
Documented refractoriness to an obinutuzumab-containing regimen
Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment withany other investigational anti-cancer agent, including chimeric antigen receptortherapy (CAR-T) within 4 weeks prior to obinutuzumab infusion
Prior solid organ transplantation
Prior allogeneic stem cell transplantation (SCT)
Autologous SCT within 100 days prior to obinutuzumab infusion
Participant with history of confirmed progressive multifocal leukoencephalopathy (PML)
Current or past history of central nervous system (CNS) lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, orneurodegenerative disease. Participants with a past history of stroke that have notexperienced a stroke or transient ischemic attack in the past 2 years and have noresidual neurologic deficits are allowed
Evidence of significant, uncontrolled concomitant diseases that could affectcompliance with the protocol or interpretation of results, including diabetesmellitus, history of relevant pulmonary disorders and known autoimmune diseases
Participants with another invasive malignancy in the last 2 years (with theexception of basal cell carcinoma and tumors deemed by the Investigator to be of lowlikelihood for recurrence)
Significant or extensive history of cardiovascular disease such as New York HeartAssociation Class III or IV or Objective Class C or D cardiac disease, myocardialinfarction within the last 6 months, unstable arrhythmias, or unstable angina
Administration of a live, attenuated vaccine within 4 weeks before obinutuzumabinfusion or anticipation that such a live attenuated vaccine will be required duringthe study
Received systemic immunosuppressive medications (including but not limited tocyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosisfactor agents) within two weeks prior to obinutuzumab infusion. Treatment withcorticosteroid
Any other diseases, metabolic dysfunction, physical examination finding, or clinicallaboratory finding giving reasonable suspicion of a disease or condition that wouldcontraindicate the use of an investigational drug
History of autoimmune disease, including but not limited to myocarditis,pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus,erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosisassociated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren'ssyndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, orglomerulonephritis. Participants with a remote history of, or well controlledautoimmune disease, may be eligible to enroll after consultation with the MedicalMonitor
In Part III diffuse large B-cell lymphoma (DLBCL) dexamethasone cohort, participantswith a history of hypersensitivity to dexamethasone or systemic corticosteroids willbe excluded
Study Design
Connect with a study center
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Prince of Wales Hospital; Haematology
Randwick, New South Wales 2031
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Gent; Neurology
Gent, 9000
BelgiumSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Praha 2, 128 08
CzechiaSite Not Available
Righospitalet, Haematologisk Klinik
Kobenhavn, 2100
DenmarkSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkActive - Recruiting
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
København Ø, 2100
DenmarkActive - Recruiting
Helsinki University Central Hospital
Helsinki, 00029
FinlandActive - Recruiting
Helsinki University Central Hospital; Dept of Oncology
Helsinki, 00029
FinlandActive - Recruiting
Hopital Henri Mondor
Creteil, 94010
FranceActive - Recruiting
Hopital Henri Mondor; Hematologie Clinique
Creteil, 94010
FranceActive - Recruiting
Hopital Claude Huriez
Lille, 59037
FranceActive - Recruiting
Hopital Claude Huriez; Hematologie
Lille, 59037
FranceActive - Recruiting
CHU Saint Eloi
Montpellier, 34295
FranceActive - Recruiting
CHU Saint Eloi; Service d'Hématologie Clinique
Montpellier, 34295
FranceActive - Recruiting
Ch Lyon Sud
Pierre Benite, 69495
FranceActive - Recruiting
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre Benite, 69495
FranceActive - Recruiting
CHU DE RENNES - CHU Pontchaillou
Rennes, 35033
FranceActive - Recruiting
CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte
Rennes, 35033
FranceActive - Recruiting
AUSL della Romagna
Ravenna, Emilia-Romagna 48121
ItalyActive - Recruiting
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
Ravenna, Emilia-Romagna 48121
ItalyActive - Recruiting
Fond. IRCCS Istituto Nazionale Tumori
Milano, Lombardia 20133
ItalyActive - Recruiting
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia
Milano, Lombardia 20133
ItalyActive - Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardia 20089
ItalySite Not Available
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardia 20089
ItalySite Not Available
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette
Torino, Piemonte 10126
ItalySite Not Available
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino, Piemonte 10126
ItalySite Not Available
Auckland Cancer Trial Centre
Auckland, 1023
New ZealandSite Not Available
Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital,
Auckland, 1023
New ZealandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, 80-952
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gdańsk, 80-214
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Pozna?, 60-569
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
Pozna?, 60-569
PolandActive - Recruiting
Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku
Poznań, 60-569
PolandSite Not Available
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
Warszawa, 02-781
PolandSite Not Available
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz
Warszawa, 02-781
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, 50-367
PolandSite Not Available
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroc?aw, 50-367
PolandSite Not Available
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Terapii Komórkowych i Chorób Wewn?trznych
Wroc?aw, 50-367
PolandCompleted
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wrocław, 50-367
PolandSite Not Available
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08915
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona 08915
SpainSite Not Available
Hospital Duran i Reynals L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
SpainSite Not Available
Hospital Duran i Reynals L'Hospitalet; Hematology Department
L'Hospitalet de Llobregat, Barcelona 08908
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035
SpainActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital del Mar; Servicio de Hematologia
Barcelona, 08003
SpainSite Not Available
Hospital Univ. 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, 28041
SpainSite Not Available
China Medical University Hospital
Taichung, 404
TaiwanActive - Recruiting
China Medical University Hospital; Oncology and Hematology
Taichung, 404
TaiwanActive - Recruiting
National Taiwan Universtiy Hospital
Taipei, 100
TaiwanSite Not Available
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, 100
TaiwanSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Ingalls Memorial Hospital
Harvey, Illinois 60426
United StatesSite Not Available
University of Kansas Medical Centre
Kansas City, Kansas 66160
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109-0934
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University; Wash Uni. Sch. Of Med
Saint Louis, Missouri 63110
United StatesActive - Recruiting
MSKCC
New York, New York 10065
United StatesCompleted
Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
Allegheny Health Network (Pittsburg PA)
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Hunstman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Virginia Commonwealth University Medical Center
Richmond, Virginia 23230
United StatesSite Not Available
Swedish Cancer Inst.
Seattle, Washington 98104
United StatesSite Not Available


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