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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)
EU CTIS ID: 2023-506820-10-00
What this study is testing
In pre-specified cohorts: To evaluate safety, tolerability, and pharmacokinetics of mosunetuzumab as a single agent and in combination with atezolizumab in patients with relapsed or refractory (R/R) non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) To determine maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of mosunetuzumab as a single agent and in combination with atezolizumab in patients with R/R NHL and CLL To identify, on the basis of safety, PK, and pharmacodynamic data, recommended Phase II dose(s) (RP2D) and schedule(s) of mosunetuzumab as a single agent and in combination with atezolizumab in patients with R/R NHL and CLL To evaluate efficacy of mosunetuzumab as a single agent and in combination with atezolizumab in patients with R/R NHL, as measured by IRF-assessed CR rate according to standard NHL response criteria To evaluate PK non-inferiority (PKNI) of mosunetuzumab subcutaneous (SC) compared to the reference mosunetuzumab Intravenous (IV) RP2D in patients with R/R FL with at least two prior lines of systemic therapy
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Agreement to provide tumor samples as follows: – For NHL patients with more than one bi-dimensionally measurable lesion (>1.5 cm in the largest dimension for nodal lesions, or >1.0 cm in its largest dimension for extranodal lesions by CT scan or MRI), agreement to undergo biopsy from a safely accessible site per investigator determination. Biopsies obtained at any time between the last dose of last prior anti-cancer therapy and the first dose of mosunetuzumab may be acceptable. – For patients with CLL: -Bone marrow biopsy and aspirate -Must have a circulating lymphocyte count of >5000/micro Litre blood
- 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of at least 12 weeks
- 3. Histologically-documented relapsed or refractory NHL or CLL expected to express the cluster of differentiation 20 (CD20) antigen and for which there is no available therapy expected to improve survival
- 4. NHL patients only: must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension for nodal lesions, or >1.0 cm in its largest dimension for extranodal lesions by CT or MRI scan)
- 5. Adequate hepatic, hematologic, and renal function
You likely can't join if
- 1. Prior treatment with systemic immunotherapeutic agents for which the mechanism of action involves T cells within 12 weeks or five half-lives of the drug, whichever is shorter, before first mosunetuzumab administration - Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first mosunetuzumab administration - Treatment with radiotherapy within 2 weeks prior to the first mosunetuzumab administration. - Received systemic immunosuppressive medications (with exceptions) within 2 weeks prior to first mosunetuzumab administration
- 2. Prior anti-lymphoma treatment with monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates within 4 weeks before first mosunetuzumab administration Autologous SCT within 100 days prior to first mosunetuzumab administration Prior treatment with CAR-T therapy within 30 days before first mosunetuzumab administration
- 3. Prior allogeneic stem cell transplantation (SCT) Prior solid organ transplantation
- 4. Patients with history of macrophage activation syndrome/hemophagocytic lymphohistiocytosis or confirmed progressive multifocal leukoencephalopathy (PML)
- 5. History of central nervous system (CNS) lymphoma or other CNS disease, autoimmune disease, other malignancy, significant cardiovascular disease, significant active pulmonary disease, known active infection (or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to first mosunetuzumab administration), or major surgery within 4 weeks prior to first mosunetuzumab administration
- 6. Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Korea, Republic of
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Korea, Republic of; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.