Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

This is an open-label, multi-center, dose escalation study of REGN1979 administered as an IV (intravenous) infusion. This phase 1 study will investigate the safety and tolerability of REGN1979 in patients with Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Official Title

An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy

Keywords

Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Antibodies, Bispecific REGN1979 multiple dose levels

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:
  2. NHL patients must have had prior treatment with an anti-CD20 antibody therapy
  3. Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT scan.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  5. Life expectancy of at least 6 months
  6. Adequate bone marrow function documented by:
  7. Platelet counts ≥75 x 109/L

  8. Hb level ≥9 g/dL
  9. Absolute neutrophil count (ANC) ≥1 x 109/L

  10. Adequate organ function
  11. Willing and able to comply with clinic visits and study-related procedures
  12. Provide signed informed consent

Key Exclusion Criteria:

  1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL
  2. History of or current relevant CNS pathology
  3. Allogeneic stem cell transplantation
  4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  5. Known hypersensitivity to both allopurinol and rasburicase
  6. History of hypersensitivity to any compound in the tetracycline antibiotics group

The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT02290951
Phase
Phase 1
Study Type
Interventional
Last Updated