AbClon announced on the 17th that it has signed a clinical trial agreement with the Korea Drug Development Fund (KDDF) for a Phase 2 trial of its novel CD19 epitope-targeting CAR-T therapy, AT101.

This Phase 2 trial is part of the National New Drug Development Project and will receive funding for two years. The primary objective is to evaluate the objective response rate, and secondary objectives include assessing tolerability, efficacy, and pharmacokinetic properties.

AT101 is a CAR-T therapy targeting CD19 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It has demonstrated promising results in a previous Phase 1 trial, also supported by the KDDF, showing a high initial response rate and encouraging follow-up data.

Currently, the Phase 2 trial is being conducted at seven hospitals across South Korea.

AbClon claims that AT101 has shown superior efficacy and durability compared to existing global CAR-T therapies, with higher initial response rates and encouraging long-term follow-up data. The unique mechanism of action of AT101, incorporating the h1218 antibody in its CAR-T construct, has been published in the prestigious journal Molecular Cancer.

"We are committed to maximizing the potential of AT101 as a globally competitive new drug by also securing treatment results for patients who are refractory to or relapse after existing CAR-T therapies," said a representative from AbClon. "Based on the clinical trial results, we will strive for expedited approval from the Ministry of Food and Drug Safety."

Meanwhile, in the Phase 1 trial, AT101 achieved a complete remission (CR) in all patients who received medium and high doses. The low-dose cohort consisted of six participants, accounting for half of the overall responses. Despite including patients who received a minimal dose—approximately 4% of the planned Phase 2 dosage—AT101 demonstrated outstanding outcomes, with an overall survival (OS) rate of 82.5% and a progression-free survival (PFS) rate of 66.7%.