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 and phase
Active, not recruiting
Phase 2
Phase 1
Conditions
Lymphocytic Leukemia, Chronic
Lymphoma, Non Hodgkin
Treatments
Drug: BTCT4465A (Mosunetuzumab) IV
Drug: BTCT4465A (Mosunetuzumab) SC
Drug: Atezolizumab
Details and patient eligibility
About
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.
Enrollment
836 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Sequential Assignment
Masking
None (Open label)
836 participants in 2 patient groups
Dose Escalation
Experimental group
Description:
Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
Treatment:
Drug: Atezolizumab
Drug: BTCT4465A (Mosunetuzumab) SC
Drug: BTCT4465A (Mosunetuzumab) IV
Dose Expansion
Experimental group
Description:
Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.
Treatment:
Drug: Atezolizumab
Drug: BTCT4465A (Mosunetuzumab) SC
Drug: BTCT4465A (Mosunetuzumab) IV
Trial contacts and locations
49
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Data sourced from clinicaltrials.gov
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