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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Previously Treated CD20+ B-cell Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

SC ocaratuzumab 40 mg weekly x 4 doses

Group Type EXPERIMENTAL

ocaratuzumab

Intervention Type BIOLOGICAL

Cohort 2

SC ocaratuzumab 80 mg weekly x 4 doses

Group Type EXPERIMENTAL

ocaratuzumab

Intervention Type BIOLOGICAL

Cohort 3

SC ocaratuzumab 80 mg weekly x 8 doses

Group Type EXPERIMENTAL

ocaratuzumab

Intervention Type BIOLOGICAL

Interventions

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ocaratuzumab

Intervention Type BIOLOGICAL

Other Intervention Names

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AME-133v, LY2469298

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No