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)

  • STATUS
    Recruiting
  • End date
    Nov 15, 2023
  • participants needed
    836
  • sponsor
    Genentech, Inc.
Updated on 20 June 2021
cancer
lymphoid leukemia
hematologic malignancy
chronic lymphocytic leukemia
lymphoma
hodgkin's disease
leukemia
cluster of differentiation

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.

Details
Condition Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl), leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma
Treatment Atezolizumab, BTCT4465A, BTCT4465A (Mosunetuzumab) IV, BTCT4465A (Mosunetuzumab) SC
Clinical Study IdentifierNCT02500407
SponsorGenentech, Inc.
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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

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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