AbClon said Monday the company would expand its phase 2 clinical trial for its chimeric antigen receptor T-cell (CAR-T) therapy candidate, AT101. to seven sites.

In addition to Asan Medical Center, Ajou University Hospital, Ulsan National University Hospital, and Dong-A University Hospital, where the phase 1 trial was conducted, AbClon is adding three new sites -- Samsung Medical Center, Seoul National University Hospital, and the Catholic University of Korea Yeouido St. Mary's Hospital.

AbClon is conducting the phase 2 trial of AT101 in patients with hematologic malignancies. On April 19, the company received approval from the Ministry of Food and Drug Safety to amend the AT101 Phase 2 clinical trial. It aims to complete phase 2 and obtain accelerated approval for AT101 in Korea.

According to the phase 1 follow-up results announced by AbClon at the International Congress of BMT and the Annual Congress of KSBMT (Korean Society for Blood and Marrow Transplantation (ICBMT 2023) on Sept. 1, AT101 showed a complete remission rate (CR) of 75 percent and an objective response rate (ORR) of 91.7 percent.

AbClon emphasized that all three patients in the low-dose group remained in complete remission more than one year after treatment, showing a differentiated effect compared to previously approved CAR-T therapies, such as Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel).

"In phase 1, we carefully administered the drug with a period between patients and dosage concentrations because patient safety is our top priority," an AbClon official said. "Now that the safety data of AT101 has been secured in phase 1, phase 2 can proceed faster than phase 1, and we have added three large hospitals to accelerate the process."