GO29781

GO29781

An open-label, multicenter, phase I/IB trial evaluating the safety and pharmacokinetics of escalating doses of 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

Disease:

Follicular lymphoma, diffuse large B-cell lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia, marginal zone lymphoma, mantle cell lymphoma, transformed indolent lymphoma

Summary:

This is a phase I study of the drug mosentuzumab (BTCT4465A) in patients with B-cell lymphoma or chronic lymphocytic leukemia that has returned after previous treatment. The medicine is given by intravenous infusion every 3 weeks. It works by activating your own immune system to attack and destroy lymphoma/leukaemia cells.

Eligibility:

Include, but not limited to, the following:

Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) of 0 or 1
2. 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
3. Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:
1. Pregnant or lactating women
2. Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
3. Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
4. Systemic immunosuppressive medication within 2 weeks prior to study drug
5. Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
6. Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
7. History of central nervous system (CNS) lymphoma or other CNS disease
8. Significant cardiovascular or pulmonary disease
9. Hepatitis B or C or human immunodeficiency virus (HIV)
10. Receipt of a live attenuated vaccine within 4 weeks prior to study drug
11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration

Contact person:

Lewis Edwards
Email ledwards@linear.org.au
Phone 6382 5125


Email
Phone

Principal Investigator:

Dr Chan Cheah

Sponsor:

Genentech

Phase:

I/Ib

Protocol Number:

GO29781

Trial Registration Number:

Clinical Trials.gov

ANZ Clinical Trial Registry