Study of REGN2810 and REGN1979 in Patients With Lymphoma or Acute Lymphoblastic Leukemia

The purpose of this study is to assess the safety and tolerability of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in patients with B-cell malignancies.

Study phase: I

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Key Inclusion Criteria for Lymphoma [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:
1. Have documented CD20+ B-cell NHL or documented HL, with active disease that is either not responsive to or relapsed after prior therapy, for whom no standard of care options exists.
2. Must have at least 1 bi-dimensionally measurable lesion (?1.5 cm) documented by diagnostic imaging (CT, PET-CT or MRI).
3. Eastern Cooperative Oncology Group (ECOG) performance status ?1
4. Life expectancy of at least 6 months
5. Adequate bone marrow function
6. Adequate organ function

Key Exclusion Criteria for Lymphoma [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:
1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by nonprimary CNS NHL
2. History of or current relevant CNS pathology
3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
4. Prior allogeneic stem cell transplantation
5. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
6. Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
7. History of hypersensitivity to any compound in the tetracycline antibiotics group
8. Known hypersensitivity to both allopurinol and rasburicase
9. Pregnant or breastfeeding women
10. Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study

Key Inclusion Criteria for Acute Lymphoblastic Leukemia (ALL):
1. Have documented CD20+ B-lineage ALL after at least induction and 1 cycle of consolidation chemotherapy
2. Eastern Cooperative Oncology Group (ECOG) performance status ?2
3. Adequate bone marrow function
4. Adequate organ function

Key Exclusion Criteria for ALL:
1. History or current central nervous system (CNS) pathology
2. Burkitt's leukemia
3. Prior allogeneic stem cell transplantation less than 3 months of treatment
4. Concurrent active malignancy for which the patient is receiving treatment
5. Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
6. History of hypersensitivity to any compound in the tetracycline antibiotics group
7. Known hypersensitivity to both allopurinol and rasburicase
8. Pregnant or breastfeeding women
9. Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study

Primary disease category: Cancer

Sponsor: Regeneron Pharmaceuticals, Inc.

Projected enrollment dates: February 2017 to May 2020

Official study title: A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Monoclonal Antibody, and REGN2810, an Anti-Programmed Death-1 Monoclonal Antibody, in Patients with B-Cell Malignancies