Curocell Applies for Phase 3 IND to Expand Rimcato's Second-Line Treatment Indication

Compared with existing standard treatment at major medical institutions in South Korea
Conducted as a randomized trial
Trial launch targeted for the first half of 2027, subject to MFDS approval

Curocell has applied for approval of an amendment to the investigational new drug (IND) plan for a Phase 3 clinical trial to expand the second-line treatment indication for Rimcato, a chimeric antigen receptor T-cell (CAR-T) therapy whose active ingredient is anbalcabtagene autoleucel.

Curocell said on October 30 that it had submitted an application to the Ministry of Food and Drug Safety (MFDS) for approval of an amendment to the Phase 3 IND for Rimcato in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Curocell corporate logo image. Curocell

The trial aims to expand Rimcato's indication from its current use in third-line or later treatment to second-line treatment. Curocell plans to begin the trial in the first half of 2027, following the MFDS approval process.

Patients with DLBCL whose disease does not respond to first-line treatment or relapses soon after treatment may not benefit sufficiently from existing second-line options: salvage chemotherapy and autologous hematopoietic stem cell transplantation. Some patients are also unable to undergo a transplant because of factors such as advanced age or comorbidities, underscoring the need for new treatment alternatives.

Globally, the use of CAR-T therapies earlier in treatment is expanding for these patient groups. Through this trial, Curocell aims to assess Rimcato's efficacy and safety as a second-line treatment and broaden the patient population eligible for the therapy in the future.

The Phase 3 trial will be conducted at multiple major medical institutions in South Korea, including Samsung Medical Center, using a randomized design. It will compare patients receiving Rimcato with those receiving existing standard treatment and assess efficacy and safety using measures including event-free survival.

Rimcato is an autologous T-cell therapy that uses Curocell's next-generation CAR-T platform, OVIS. It is designed to simultaneously reduce the expression of PD-1 and TIGIT, immune checkpoint proteins that suppress CAR-T cell function. Curocell also operates a commercial CAR-T manufacturing facility capable of handling development, production, and supply in-house.

Curocell CEO Kim Geonsu said, "Following Rimcato's approval this year, which is helping usher in the era of commercialized domestically developed CAR-T therapies, this Phase 3 IND application marks an important first step toward expanding Rimcato beyond third-line or later treatment into earlier stages of care. We plan to launch the full-scale Phase 3 trial in the first half of 2027 following a swift approval process. We will actively pursue an expanded second-line indication so that patients urgently in need of an alternative after first-line treatment fails can access CAR-T therapy sooner."

In the first half of this year, Rimcato received marketing approval from the MFDS as a third-line treatment for adults with relapsed or refractory DLBCL. It is currently undergoing the process for inclusion in the National Health Insurance coverage list. Curocell aims to secure coverage and begin commercial treatment before the end of the year.

This content was produced with the assistance of AI translation services.