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

February 28, 2014 updated by: Mentrik Biotech, LLC

A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Universtity of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
SC ocaratuzumab 40 mg weekly x 4 doses
Biological: ocaratuzumab
Other Names:
  • AME-133v, LY2469298
EXPERIMENTAL: Cohort 2
SC ocaratuzumab 80 mg weekly x 4 doses
Biological: ocaratuzumab
Other Names:
  • AME-133v, LY2469298
EXPERIMENTAL: Cohort 3
SC ocaratuzumab 80 mg weekly x 8 doses
Biological: ocaratuzumab
Other Names:
  • AME-133v, LY2469298

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters following SC ocaratuzumab administration such as area under the curve, maximum serum drug concentration, and elimination half life
Time Frame: Every office visit throughout the study for up to 12 months
Every office visit throughout the study for up to 12 months
Pharmacodynamic profile of B-cell depletion and re-population as measured by CD19+ peripheral blood B lymphocyte count
Time Frame: Baseline, day 1 and 8, 1 mon, 3 mon, 6 mon, and 12 mon post-treatment
Baseline, day 1 and 8, 1 mon, 3 mon, 6 mon, and 12 mon post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of SC ocaratuzumab administration as described by the incidence of adverse events such as local injection site reactions or laboratory abnormalities
Time Frame: Every office visit throughout the study for up to 12 months
Every office visit throughout the study for up to 12 months
Immunogenicity as measured by the incidence, titre of human anti-human antibody (HAHA) immune response
Time Frame: Baseline, 1 mon, 2 mon, 3 mon, 6 mon, and 12 mon post-treatment
Baseline, 1 mon, 2 mon, 3 mon, 6 mon, and 12 mon post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mentrik Biotech, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (ESTIMATE)

May 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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