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

Trial Status: Active

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 B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

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.
  • Patients with NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL are not required to have received prior treatment with an anti-CD20 antibody therapy, provided the patient has failed either a BTK inhibitor or PI3K inhibitor and the treating physician deems it appropriate for the patient to be entered into a phase 1 trial.
  • For inclusion in the FL grade 1-3a expansion cohort, patients must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
  • For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.
  • Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI 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 documented by:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN
  • Total bilirubin ≤1.5 X ULN
  • Calculated creatinine clearance by Cockcroft-Gault ≥50 mL/min (patients with borderline creatinine clearance by Cockcroft-Gault may be considered for enrollment if a measured creatinine clearance (based on 24-hour urine or other reliable method) is ≥50 mL/min)
  • 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). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.
  • Known hypersensitivity to both allopurinol and rasburicase
  • History of hypersensitivity to any compound in the tetracycline antibiotics group

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Brigham and Women's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Regeneron Pharmaceuticals, Inc.

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