Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies

Status: In Review

Description

Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function. A previous phase I / II study of intravenously (IV) administered ocaratuzumab in refractory / relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg / m2 weekly for four weeks. In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.

Eligibility Criteria

Inclusion Criteria

  • Age >18 years;
  • Histologically confirmed diagnosis of a CD20+ B-cell malignancy;
  • Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
  • Appropriate for single agent study drug therapy as prescribed by this protocol;
  • ECOG performance status 0 to 2;
  • Adequate hematopoietic, renal, and hepatic functions defined as:
  • Absolute neutrophil count greater than 1000 /mm³
  • Platelet count greater than 75,000/mm³
  • Hemoglobin greater than 8.5 g/dL
  • Serum creatinine ≤ 1.5x upper limit of normal
  • AST, ALT, and total bilirubin ≤ 3x upper limit of normal;
  • Ability to understand and the willingness to sign a written informed consent document;
  • Life expectancy of 6 months or greater.

Exclusion Criteria

  • Anti-CD20 therapy within 4 weeks of enrollment;
  • Systemic chemotherapy or immunotherapy within 14 days of enrollment;
  • Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
  • Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
  • Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.
  • Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition;
  • Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
  • Women who are pregnant or breast-feeding;
  • Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
  • Psychiatric illness/social situations that would limit compliance with study requirements;
  • Participation in other investigational studies while enrolled on this trial.

Locations & Contacts

Location information is not yet available.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Mentrik Biotech, LLC

Trial IDs

Primary ID MEN-001
Secondary IDs NCI-2013-01989
Clinicaltrials.gov ID NCT01858181