Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Study Overview
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Brief Summary
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To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.

Detailed Description
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Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.

Official Title
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A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Conditions
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Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Intervention / Treatment
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* Biological: MDX-1411


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy; Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy For MCL, must have measurable disease At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL; At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411 ECOG Performance Status 0 to 2; No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C; Exclusion Criteria: History of severe hypersensitivity reactions to other monoclonal antibodies; Use of other investigational drugs within 30 days before study drug administration Prior treatment with any other anti-CD70 antibody; Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411; Evidence of bleeding diathesis or coagulopathy; Active autoimmune disease requiring immunosuppressive therapy; Known current drug or alcohol abuse; Underlying medical conditions that will make the administration of MDX-1411 hazardous

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDX1411<br>An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study. | Biological: MDX-1411<br>* Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) |  | Day 1-40 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medarex Inc.