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

Status unconfirmed · Phase 1

Conditions studied: Previously Treated CD20+ B-cell Malignancies

In brief

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.

Key facts

Study ID

NCT01858181

Run by

Mentrik Biotech, LLC

People needed

9

Starts

2015-01-01

Last updated by the study team

2014-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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