Curocell's independently developed CAR-T therapy Anbal-cel has improved long-term survival and demonstrated a high treatment response rate in patients with hematologic malignancies in a phase 2 clinical trial, enabling it to proceed to commercialization.

Curocells said Friday that it presented top-line results from the phase 2 trial of Anbal-cel, a CD19-targeted CAR-T therapy, at the 18th International Congress of Medical Lymphoma (ICML 2025) in Lugano, Switzerland.

The multi-institutional, single-arm phase 2 trial was conducted at six major Korean university cancer centers in patients with relapsed or refractory diffuse large B-cell lymphoma (LBCL). Its purpose was to evaluate the safety and efficacy of Anbal-cel.

Seventy-nine patients received Anbal-cel, with 75.3 percent (55 patients) achieving an objective response rate (ORR) and 67.1 percent (53 patients) achieving a complete response (CR). With a median follow-up of 8.5 months, long-term follow-up showed 12- and 18-month progression-free survival (PFS) rates of 41.1 percent and 35.2 percent, and overall survival (OS) rates of 66.6 percent and 57.3 percent.

Curocell confirmed the median progression-free survival (mPFS) for Anbal-cel at 6.0 months, two times longer than the mPFS in the Kymriah trial (2.9 months).

Anbal-cel also showed a favorable safety profile. Grade 3 or higher cytokine release syndrome (CRS) occurred in 8.9 percent and immune effector cell-associated neurotoxicity syndrome (ICANS) in 3.8 percent, with no grade 4 or more severe CRS.

The presentation also included an analysis of the immunophenotypic differences in CAR-T cells.

The researchers defined long-term responders (LRs) as patients who maintained complete remission for at least six months. They compared them to non-responders and found that LRs had significantly lower immune checkpoint receptors PD-1 and TIGIT expression. These were identified as key biomarkers closely related to the maintenance of antitumor function and treatment responsiveness of CAR-T cells.

“Following our oral presentation at ICML 2023, this announcement is conclusive proof of Anbal-cel's clinical efficacy and safety,” Curocell CEO Kim Gun-soo said. “We are working closely with the Ministry of Food and Drug Safety, which is leading the regulatory science to provide more effective and sustainable treatment options for Korean patients. We hope to make a success story of domestic CAR-T therapy development through early approval.”