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MDX-1342 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Patients will receive active MDX-1342. |
| Name | Type | Description |
|---|---|---|
| MDX-1342 | BIOLOGICAL | 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. |
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 transplan...
MDX-1342 is an investigational monoclonal antibody developed by Bristol-Myers Squibb Company (ticker BMY). It was studied in Phase 1 clinical trials for two indications: chronic lymphocytic leukemia and rheumatoid arthritis. It is a CD19-targeted binding agent and has not been approved by the FDA.
MDX-1342 was studied for the treatment of chronic lymphocytic leukemia and rheumatoid arthritis. Both were Phase 1 investigations. In rheumatoid arthritis it was evaluated in combination with methotrexate. The program is not currently active, with all listed trials completed.
MDX-1342 targets CD19, a cell surface protein found on B cells. As a monoclonal antibody binding agent, it is designed to bind CD19. Targeting CD19 is relevant to B-cell malignancies such as chronic lymphocytic leukemia and to autoimmune conditions such as rheumatoid arthritis, where B cells play a role.
Bristol-Myers Squibb Company, which trades under the ticker BMY, developed MDX-1342. The company sponsored the Phase 1 clinical program for the antibody in chronic lymphocytic leukemia and rheumatoid arthritis.
MDX-1342 is in Phase 1. It is investigational and has not been approved by the FDA. Two Phase 1 trials were conducted, both now completed, with no active trials listed. One trial enrolled 26 patients with rheumatoid arthritis and the other enrolled 15 patients with chronic lymphocytic leukemia.
MDX-1342 was studied in two completed Phase 1 trials. NCT00639834 evaluated its safety in combination with methotrexate in rheumatoid arthritis patients across the United States, Germany, Hungary, Ukraine, and the United Kingdom. NCT00593944 studied MDX-1342 in patients with chronic lymphocytic leukemia in the United States.