Trial Search Results

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

This is a first-in-human study to evaluate the safety and anticancer activity of REGN1979. If results are encouraging, study will lead to development of a novel therapy regimen for patients who have not responded to the current standard of care.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Intervention(s):

  • Drug: REGN1979 multiple dose levels

Phase:

Phase 1

Eligibility


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:

      1. Platelet counts ≥75 x 10^9/L

      2. Hb level ≥9 g/dL

      3. Absolute neutrophil count (ANC) ≥1 x 10^9/L

   7. Adequate organ function

   8. Willing and able to comply with clinic visits and study-related procedures

   9. 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
650-736-2563
Recruiting