Trial Search Results

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
  • Drug: Rituximab

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. 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.

   3. Must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or
   MRI 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 documented by:

      1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X ULN

      2. Total bilirubin ≤1.5 X ULN

      3. 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)

   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). 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.

   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
Chaitasi Majmudar
650-736-0959
Recruiting