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REGN1979


Title An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, An Anti-CD20 X Anti-CD3 Bispecific Antibody, In Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Therapeutic Area Lymphomas (adult)
Principal Investigator Andreas Klein, MD
Min Age 18 Years
Gender Male or Female
Contact NCCCR
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03888105?term=the+Anti-Tumor+Activity+and+Safety+of+REGN1979&cond=lymphoma&draw=2&rank=1

Overview

This is a phase 2, open-label, multi-cohort, multi-center study of REGN1979 administered as an IV infusion in patients with B-NHL that has relapsed after or is refractory to prior systemic therapy. This study consists of 5 disease specific cohorts, each with independent parallel enrollment. 

Study Details

Inclusion Criteria

 Key Inclusion Criteria:

  • For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
  • Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
  • DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
  • MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice
  • MZL cohort: New enrollment is paused until further notice
  • Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
  • Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
  • Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, hepatic, and renal function as defined in the protocol

Exclusion Criteria

Key Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
  • Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
  • History of allogeneic stem cell transplantation
  • Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
  • History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
  • Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol
  • Known hypersensitivity to both allopurinol and rasburicase
  • Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Study Requirements

The duration of the study will depend on how patients respond to the treatment. The study consists of a screening period of up to 28 days, a treatment period during which you will receive REGN1979 until disease progression, a follow-up period after the completion of the study drug treatment period that will last until withdrawal of consent or the study is over. CT scans and blood draws will be collected during the course of the study.