Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)

A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00593944

Acronym

MDX1342-02

Enrollment

Registered

2008-01-15

Start date

2008-08-31

Completion date

2010-05-31

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, Chronic Lymphocytic Leukemia, B cell, leukemia, lymphocyte, antibody, monoclonal, cancer, blood

Brief summary

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Detailed description

Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

Interventions

BIOLOGICALMDX-1342

MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* relapsed/refractory CD19-positive CLL * At least 28 days since prior treatment for CLL * ECOG PS 0-2 * Screening laboratory values must be met

Exclusion criteria

* No prior anti-CD19 antibody tx * No active, uncontrolled infection * No prior allogeneic bone marrow transplant * No autoimmune disease

Design outcomes

Primary

Measure	Time frame
incidence and severity of treatment-emergent adverse events	all events will be followed to resolution

Secondary

Measure	Time frame
clinical laboratory tests	study duratation - each visit
physical examination	study duration - each visit
response	12 weeks
diagnostic testing	at screening and study completion
pharmacokinetics sampling	at each dosing visit
electrocardiogram	at screening and study completion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026