EMA Approves Clinical Trial Application for Allogeneic CAR-T

By Cecilia Brown - Last Updated: August 11, 2023

The European Medicines Agency has approved a Clinical Trial Application for AVC-201 in relapsed or refractory acute myeloid leukemia (AML) and other CD123-positive hematologic malignancies.

AVC-201 is a CRISPR-engineered allogeneic switchable chimeric antigen receptor (CAR) T-cell therapy candidate “designed to target and eliminate cells expressing receptor CD123, which is known to be overexpressed in nearly all [cases of AML], and several other hematological malignancies,” according to a news release from AvenCell Therapeutics, Inc., the manufacturer of AVC-201.

The open-label phase I study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AVC-201. It will be conducted at multiple sites in Germany and will include up to 35 patients.

The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures of the trial include efficacy, safety, and CAR-T persistence. The study will use a single-ascending dose design to identify two dose levels of AVC-201 that will be further evaluated in a phase II study.

Source: PR Newswire, August 2023

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