Phase
Condition
Lymphoma
Platelet Disorders
Non-hodgkin's Lymphoma
Treatment
CC-99282
SC Mosunetuzumab
Obinutuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >/= 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
History of one of the following histologically documented hematologic malignanciesthat are expected to express the CD20 antigen: In the Dose Escalation phase,participants must have relapsed after or failed to respond to at least two priorlines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line ofsystemic therapy and must require systemic therapy. Participants withDLBCL/transformed FL must have relapsed after or failed to respond to at least oneprior systemic treatment regimen.
Participants with DLBCL/transformed FL who have received only one prior line oftherapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response toprior treatment, or have refused ASCT; or be ineligible for or unable to receivechimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by theprotocol
Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)
At least one bi-dimensionally measurable nodal lesion (> 1.5 cm in its largestdimension by diagnostic quality CT or PET/CT scan), or at least one bi-dimensionallymeasurable extranodal lesion (> 1.0 cm in its largest dimension by diagnosticquality CT or PET/CT scan)
Availability of a representative tumor specimen and the corresponding pathologyreport for confirmation of the diagnosis of NHL
A fresh pretreatment biopsy during screening period, excisional or incisional, ispreferred
Adequate hematologic function without growth factors or blood product transfusionwithin 14 days of first dose of study drug administration
Normal laboratory values
All participants and health care providers will be trained and counseled onpregnancy prevention. For female participants of childbearing potential: agreementto remain abstinent (refrain from heterosexual intercourse) or use contraceptionduring the treatment period and for 3 months after the final dose of mosunetuzumab,at least 18 months after pre-treatment with obinutuzumab or 2 months after the lastdose of glofitamab, 28 days after the last dose of CC-220, 28 days after the lastdose of CC-99282, 3 months after the last dose of tocilizumab (if applicable),whichever is longer
For male participants: agreement to remain abstinent (refrain from heterosexualintercourse) or use a condom, and agree to refrain from donating sperm during thetreatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose oftocilizumab (if applicable), whichever is longer
Exclusion
Exclusion Criteria:
Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancytest result within 14 days prior to initiation of the study treatment) or within 3months after the final dose of mosunetuzumab, at least 3 months after pre-treatmentwith obinutuzumab or 2 months after the last dose of glofitamab, whichever islonger, 28 days after the last dose of CC-220, 28 days after the last dose ofCC-9282, 3 months after the final dose of tocilizumab, whichever is longer
Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g.,lenalidomide, avadomide/CC-122, pomalidomide) </= 4 weeks prior to starting CC-220and/or CC-99282
Inability to swallow pills, or persistent diarrhea or malabsorption >= Grade 2National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management
QTc interval of > 470 ms
The following treatments prior to study entry: mosunetuzumab, glofitamab, or otherCD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solidorgan transplantation
Treatments (investigational or approved) within the following time periods prior toinitiation/first dose of study treatment: radiotherapy within 2 weeks; autologousSCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days;prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugateswithin 4 weeks; use of radioimmunoconjugates within 12 weeks; systemicimmunosuppressive medications within 2 weeks; any other anti-cancer therapy, whetherinvestigational or approved, including but not limited to chemotherapy, within 4weeks or 5 half-lives of the drug, whichever is shorter
Live, attenuated vaccine within 4 weeks before first dose of study treatment, or inwhom it is anticipated that such a live attenuated vaccine will be required duringthe study period or within 5 months after the final dose of study treatment
Current or past history of central nervous system (CNS) lymphoma or leptomeningealinfiltration
History of severe allergic or anaphylactic reactions to humanized or murinemonoclonal antibody therapy (or recombinant antibody-related fusion proteins)
History of autoimmune disease, including but not limited to myocarditis,pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupuserythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosisassociated with antiphospholipid syndrome, granulomatosis with polyangiitis,Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, orglomerulonephritis
Major surgery or significant traumatic injury < 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during studytreatment
Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per US national cancer institute (NCI) common terminology criteria foradverse events (CTCAE) v5.0) prior to the first study drug administration withexceptions defined by the protocol
Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary,liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliancewith the protocol or interpretation of results
For participants enrolled into glofitamab cohort: documented refractoriness to anobinutuzumab monotherapy-containing regimen (defined as disease that did not achieveresponse (PR or CR) or progressed within 6 months of the last dose of anobinutuzumab-containing regimen)
Study Design
Connect with a study center
Soroka
Be'er Sheva, 0084101
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa, 3109600
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah Medical Center; Pulmonary Institute
Jerusalem, 9112001
IsraelActive - Recruiting
Center Hospital
Ramat Gan, 5262199
IsraelActive - Recruiting
Sourasky Medical Center
Tel-Aviv, 6423900
IsraelActive - Recruiting
Sourasky Medical Center; Oncology Department
Tel-Aviv, 6423900
IsraelActive - Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna 40138
ItalyActive - Recruiting
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola, Emilia-Romagna 47014
ItalyActive - Recruiting
ASST Spedali Civili di Brescia
Brescia, Lombardia 25123
ItalyActive - Recruiting
Irccs Ospedale San Raffaele
Milano, Lombardia 20132
ItalyActive - Recruiting
Irccs Ospedale San Raffaele;U.O. Oculistica
Milano, Lombardia 20132
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa, Piemonte 56126
ItalyActive - Recruiting
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona 08908
SpainActive - Recruiting
ICO L'Hospitalet; Servicio de Farmacia
L'Hospitalet de Llobregat, Barcelona 08908
SpainActive - Recruiting
Hospital Universitario La Fe
València, Valencia 46026
SpainActive - Recruiting
Hospital Universitario La Fe; Hospital La Fe
València, Valencia 46026
SpainActive - Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
SpainActive - Recruiting
Clinica Universidad de Navarra-Madrid
Madrid, 28027
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28040
SpainActive - Recruiting
Hosp Universitario Salamanca
Salamanca, 37007
SpainActive - Recruiting
Western General Hospital; Edinburgh Cancer Center
Edinburgh, EH4 2XU
United KingdomSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN
United KingdomActive - Recruiting
NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United KingdomActive - Recruiting
University College London Hospitals
London, W1T 7HA
United KingdomActive - Recruiting
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB
United KingdomActive - Recruiting
Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team
Nottingham, NG5 1PB
United KingdomActive - Recruiting
Oxford University Hospitals NHS Trust; Churchill Hospital; Clinical Trials Pharmacy Department
Oxford, OX3 7LE
United KingdomActive - Recruiting
Oxford University Hospitals NHS Trust;Churchill Hospital
Oxford, OX3 7LE
United KingdomActive - Recruiting
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco, California 94143
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesActive - Recruiting
The University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
UT MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
UT MD Anderson Cancer Center; Investigational Pharmacy
Houston, Texas 77030
United StatesActive - Recruiting
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