A Phase 1 Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies

Status: Active

Description

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)

Eligibility Criteria

Inclusion Criteria

  • 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:
  • NHL patients must have had prior treatment with an anti-CD20 antibody therapy
  • Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT scan.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Life expectancy of at least 6 months
  • Adequate bone marrow function documented by:
  • Platelet counts ≥75 x 10^9/L
  • Hb level ≥9 g/dL
  • Absolute neutrophil count (ANC) ≥1 x 10^9/L
  • Adequate organ function
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion Criteria

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

Locations & Contacts

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Regeneron Pharmaceuticals, Inc.

Trial IDs

Primary ID R1979-HM-1333
Secondary IDs NCI-2015-00136, 2015-004491-30
Clinicaltrials.gov ID NCT02290951