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Orphan Drug Designation Given to Bispecific Antibody CLL Treatment

By: JNCCN 360 Staff
Posted: Tuesday, November 16, 2021

On October 15, the U.S. Food and Drug Administration granted Orphan Drug designation to the CD1d-targeted agent known as LAVA-051 for chronic lymphocytic leukemia (CLL) treatment. The bispecific antibody works to promote immune activation against cancerous cells that express the CD1d marker.

Previous preclinical models found the bispecific antibody both safe and effective. A phase I/II clinical trial studying the safety and efficacy of LAVA-051 is currently underway. The trials are recruiting patients with hematologic malignancies, including CD1d-positive CLL, multiple myeloma, and acute myeloid leukemia (AML).

All enrolled patients must have tumor cell CD1d expression and no longer respond to or have  or experienced release after prior therapies. Additionally, patients must have exhausted all other standard options; have an estimated life expectancy of at least 3 months; have an Eastern Cooperative Oncology Group performance status of 0 or 1; as well as have renal, hepatic, and hematologic function.

In phase I, patients will be given LAVA-051 at various doses via intravenous infusion until the estimated therapeutic dose is attained. The goal is to limit toxicities in the first 28 days of treatment and study the pharmacokinetics of LAVA-051. In phase II, patients with multiple myeloma, CLL, and AML will be administered the therapeutic dose to study the treatment’s antitumor response as well as the frequency and severity of adverse events.



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