A Safety 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)

  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
Trial Status:

Recruiting

This trial runs in
Cities
  • Adelaide
  • Barcelona
  • Clayton
  • Commack
  • Darlinghurst
  • Denver
  • Dortmund
  • Duarte
  • Fitzroy
  • Hackensack
  • Harrison
  • Heidelberg
  • Hobart
  • Houston
  • Köln
  • London
  • Madrid
  • Mainz
  • Manchester
  • Montréal
  • Montvale
  • München
  • Münster
  • Nashville
  • Nedlands
  • New Haven
  • New York
  • Pamplona
  • Philadelphia
  • Salamanca
  • San Diego
  • Santa Barbara
  • Seattle
  • Seoul
  • South Brisbane
  • Springfield
  • St. Louis
  • Sutton
  • Toronto
  • Vancouver
  • Woolloongabba
  • Würzburg
Trial Identifier:

NCT02500407 GO29781

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02500407 , GO29781 Trial Identifier
      BTCT4465A (Mosunetuzumab) IV, Atezolizumab, BTCT4465A (Mosunetuzumab) SC Treatments
      Lymphocytic Leukemia, Chronic, Lymphoma, Non Hodgkin Condition
      Official Title

      An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Key Inclusion Criteria:

      • 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

      Key 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

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