Last updated on August 2019

A Dose Escalation Study of RO7082859 as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Depending upon study part, a history or status of: 1) a histologically-confirmed hematological malignancy that is expected to express cluster of differentiation (CD)20; 2) relapse after or failure to respond to at least one prior treatment regimen; and 3) no available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [SCT])
  • Participant must have at least one measureable target lesion (>/=1.5 centimeters [cm]) in its largest dimension by computerized tomography [CT] scan)
  • 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 (</=) 1
  • Adequate liver, hematological and renal function
  • Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection
  • Negative test results for Hepatitis C virus (HCV) and human immunodeficiency virus (HIV)

Exclusion Criteria:

  • Participants with chronic lymphocytic leukemia (CLL), Burkitt lymphoma and lymphoplasmacytic lymphoma
  • Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical 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 major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
  • Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal 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 prior immunotherapeutic agents
  • Documented refractoriness to an obinutuzumab-containing regimen
  • Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks prior to obinutuzumab infusion
  • Prior solid organ transplantation
  • Prior allogeneic 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
  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
  • Participants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)
  • Administration of a live, attenuated vaccine within 4 weeks before obinutuzumab infusion or anticipation that such a live attenuated vaccine will be required during the study
  • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment </=25 mg/day prednisone or equivalent within 2 weeks prior to obinutuzumab infusion
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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