Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
Tocilizumab
Obinutuzumab
RO7443904
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body weight >=40 kg
Histologically confirmed hematological malignancy that is expected to express CD19and CD20 and with clinical evidence of treatment need; 2) relapse after or failureto respond to at least two prior treatment regimens; and 3) no other availabletreatment options that are known to provide clinical benefit
Must have at least one measurable target lesion (>=1.5 cm) in its largest dimensionby computed tomography (CT) scan
Able and willing to provide a fresh tumor biopsy from a safely accessible site, perInvestigator's determination
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of >=12 weeks
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 HIV
A female participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least one of the following conditions applies: 1) Women ofnon-childbearing potential 2) Women of childbearing potential (WOCBP), who, agree toremain abstinent (refrain from heterosexual intercourse) or use of one highlyeffective contraceptive method during the treatment period and for at least 18months after obinutuzumab or 5 months after the final dose of RO7443904, 2 monthsafter final dose of glofitamab or 3 months after the final dose of tocilizumab
Male participants must remain abstinent (refrain from heterosexual intercourse) oruse contraceptive measures such as a condom plus an additional contraceptive methodwith a partner who is a WOCBP during the treatment period and for at least 3 monthsafter obinutuzumab, 5 months after the final dose of RO7443904, 2 months after thefinal dose of glofitamab or 2 months after the final dose of tocilizumab, whicheveris longer
Exclusion
Exclusion Criteria:
Circulating lymphoma cells, defined by out-of-range (high) absolute lymphocyte count (ALC) or the presence of abnormal cells in the peripheral blood signifyingcirculating lymphoma cells
Participants with known acute bacterial, viral, or fungal infection 72 hours priorto glofitamab infusion
Participants with known active infection or reactivation of a latent infection
Pregnant, breastfeeding, or intending to become pregnant during the study
Prior treatment with systemic immunotherapeutic agents
History of treatment-emergent, immune-related adverse events (AEs) associated withprior immunotherapeutic agents
Persistent AEs from prior anti-cancer therapy Grade >=1
Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment withany other investigational or approved anti-cancer agent
Prior solid organ transplantation
Prior allogeneic stem cell transplant (SCT)
Autologous SCT within 100 days prior to obinutuzumab infusion
Autoimmune disease in active phase or exacerbation/flare within at least 6 months ofenrollment
History of immune deficiency disease that increases the risk of infection
History of contraindication and/or severe allergic or anaphylactic reactions tomonoclonal antibody therapy and/or prophylactic drugs used for cytokine releasesyndrome (CRS) and tumor lysis syndrome (TLS)
History of confirmed progressive multifocal leukoencephalopathy
Current or past history of central nervous system (CNS) lymphoma or CNS disease
Evidence of significant, uncontrolled concomitant diseases that could affectcompliance with the protocol or interpretation of results
Major surgery or significant traumatic injury <28 days prior to the GpT infusion oranticipation of the need for major surgery during study treatment
Participants with another invasive malignancy in the last 2 years
Significant cardiovascular disease
Administration of a live, attenuated vaccine within 4 weeks before GpT infusion oranticipation that such a live attenuated vaccine will be required during the study
Received systemic immunosuppressive medications for reasons other than anticancertherapy within the last 6 months of enrollment with the exception of corticosteroidtreatment <= 25 mg/day prednisone or equivalent
History of illicit drug or alcohol abuse within 12 months prior to screening, in theInvestigator's judgment
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
Study Design
Connect with a study center
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne, Victoria 3002
AustraliaSite Not Available
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
København Ø, 2100
DenmarkSite Not Available
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang
Lille, 59037
FranceSite Not Available
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo, Lombardia 24127
ItalySite Not Available
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardia 20089
ItalySite Not Available
Leicester Royal Infirmary; Dept of Haematology
Leicester, LE1 5WW
United KingdomSite Not Available
MSKCC
New York, New York 10065
United StatesSite Not Available
Cleveland Clinic Foundation; Hematology and Oncology
Cleveland, Ohio 44195
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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