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Lumiliximab with FCR · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Lumiliximab with FCR | DRUG | Dose, schedule, and duration specified in protocol |
Inclusion Criteria: * Age: 18 years and older * Diagnosis of B-cell CLL by International Workshop on CLL (IWCLL) response criteria * Relapsed CD23+ B-cell CLL * Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling or peripheral lymphocyt...
Lumiliximab with FCR is an investigational treatment studied in chronic lymphocytic leukemia (CLL). The combination pairs lumiliximab, a monoclonal antibody, with FCR, a chemotherapy and immunotherapy regimen. It was evaluated specifically in patients with relapsed CLL, meaning disease that returned after earlier treatment.
Lumiliximab targets FCER2, also known as CD23, a receptor found on the surface of B cells. It acts as an antagonist at this target. In chronic lymphocytic leukemia, CD23 is expressed on the malignant B cells, making it a relevant target for an antibody-based approach.
Lumiliximab was developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. The company sponsored the clinical study of lumiliximab combined with FCR in relapsed chronic lymphocytic leukemia.
Lumiliximab with FCR is in Phase 1 development. It is investigational and has not been approved by the FDA. The single Phase 1 trial of the combination has been completed, and no trials of this combination are currently active.
The combination was studied in one completed Phase 1 trial, NCT00103558, titled Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL). The trial enrolled 31 participants in the United States, was uncontrolled, and was not randomized or double blinded.