[Edaily Reporter NA EUN-KYUNG ] Curocell Inc.(372320)is moving to expand the second-line treatment indication for “Limkato,” Korea’s first domestically developed chimeric antigen receptor T-cell (CAR-T) therapy.

Curocell Inc. announced on the 30th that it has submitted an application to the Ministry of Food and Drug Safety for approval to amend its Investigational New Drug (IND) application to expand the second-line treatment indication for “Limcato” (generic name: anvalcapten-autolysate), a therapy for relapsed or refractory adult large B-cell lymphoma.

Last April, Limkato received marketing approval from the Ministry of Food and Drug Safety (MFDS) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have received two or more prior systemic therapies. This clinical trial aims to expand the indication for Limkato—which is currently approved for use as a third-line or later treatment—to include its use as a second-line therapy.

CAR-T is a personalized cell therapy in which T cells—a type of immune cell—are harvested from a patient’s blood, genetically engineered to recognize and attack cancer cells, and then reinfused into the patient. Limkato targets the CD19 protein expressed in B-cell lymphoma. By applying Curocell Inc.’s proprietary “OVIS” platform, it is designed to simultaneously reduce the expression of the immune checkpoint proteins PD-1 and TIGIT, which suppress the anticancer function of T cells.

Currently, there is a trend toward earlier use of CAR-T therapy in the treatment of relapsed or refractory large B-cell lymphoma. In particular, for patients who do not respond to first-line anticancer therapy or who relapse within 12 months after treatment completion, it is difficult to achieve sufficient therapeutic efficacy with conventional salvage chemotherapy and autologous hematopoietic stem cell transplantation alone; therefore, CAR-T has established itself as a major second-line treatment option.

In the global market, Gilead Sciences’ “Yescarta” (axicaptagin silorucel) and Bristol Myers Squibb (BMS)’s “Breyanzi” (lisocaptagin mararucel) are leading CAR-T therapies for second-line treatment. Both products secured second-line treatment indications by demonstrating improved event-free survival (EFS) compared to existing standard therapies in the global Phase 3 clinical trials ZUMA-7 and TRANSFORM, respectively. In contrast, Novartis’ “Kymriah” (tisagenlecleucel) failed to meet the primary efficacy endpoint in the Phase 3 second-line treatment trial BELINDA.

In this clinical trial, Curocell Inc. will also directly compare the efficacy of Limkato as a second-line treatment against the existing standard of care. Conducted as a multicenter, randomized trial at major domestic medical institutions, including Samsung Medical Center, the study will evaluate the efficacy and safety—including event-free survival—of the Limkato treatment group and the standard-of-care group. Event-free survival refers to the period during which no predefined events, such as disease progression or treatment failure, occur.

For Limcato to be used as a second-line treatment in practice, it must demonstrate therapeutic efficacy in this clinical trial and obtain additional marketing authorization.

Curocell Inc. is currently pursuing health insurance coverage for existing indications involving third-line or later treatments. The company is proceeding with the coverage process through the “approval-evaluation linkage system” and aims to secure coverage and begin commercial patient treatment by the end of the year. Once the second-line treatment indication is secured, the patient population eligible for Rimcato is expected to expand.

Kim Geon-soo, CEO of Curocell Inc., stated, “Following the opening of the era of commercialization for domestically developed CAR-T therapies through Rimcato’s approval this year, this Phase 3 IND application is an important first step toward expanding Rimcato’s use beyond third-line or later treatments to earlier stages of treatment,” adding “We plan to begin full-scale Phase 3 trials in the first half of 2027 following an expedited approval process, and we will actively pursue the expansion of the second-line treatment indication so that we can provide CAR-T therapy more quickly to patients who urgently need an alternative after failing first-line treatment,” he said.