Appclon, Increased Treatment Success with CAR-T Rapid Test Approval..."Smooth Progress in Interim Clinical Results"

Appclon announced on the 20th that the Ministry of Food and Drug Safety has approved a change to the rapid testing method for the chimeric antigen receptor T-cell (CAR-T) therapy AT101. AT101 is currently undergoing Phase 2 clinical trials.

The previously required 14 to 18 days for sterility testing and 33 to 42 days for replication-competent virus testing in the manufacturing process have been shortened to 7 days and 1 day, respectively. It is expected that the entire process?from manufacturing the AT101 therapy using blood cells from patients in clinical trials, completing quality inspections, to administering the final AT101?will be possible within three weeks.

The clinical indication for AT101, diffuse large B-cell lymphoma, is a rapidly growing malignant lymphoma. The longer the CAR-T therapy manufacturing period, the higher the likelihood of rapid deterioration in the patient's condition. Therefore, the prompt administration of CAR-T cell therapy is a critical factor for treatment success.

An Appclon representative stated, "By introducing the rapid testing method, we have been able to reduce the time required for quality inspection to less than half of the previous duration," adding, "This will allow us to administer AT101 quickly and advance the point at which patients experience therapeutic effects."

They further emphasized, "We expect this to have a positive impact on the clinical outcomes of AT101," and highlighted, "The Phase 2 clinical trial of AT101 is progressing smoothly with the goal of announcing interim results in the second half of this year."

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