A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

 Chronic Lymphocytic Leukaemia (CLL) / Posted 9 months ago

Brief Summary
This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years and older
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
    • Adequate hepatic, hematologic, and renal function
  • Exclusion Criteria :
    • Pregnant or lactating women
    • Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
    • Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
    • Systemic immunosuppressive medication within 2 weeks prior to study drug
    • Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
    • Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
    • History of central nervous system (CNS) lymphoma or other CNS disease
    • Significant cardiovascular or pulmonary disease
    • Hepatitis B or C or human immunodeficiency virus (HIV)
    • Receipt of a live attenuated vaccine within 4 weeks prior to study drug
    • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration
  • Study start date : September 15, 2015
  • Study end date : March 17, 2023
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Clinical Trials, Hoffmann-La Roche
Contact details

Barts Cancer Institute, LondonLondon,England,E1 2AT  Show Phone Number global-roche-genentech-trials@gene.com www.bartscancer.london

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