Curocell's CD19-targeting CAR-T therapy, Anbal-cel approved for Phase 1/2 꽁 머니 바카라 trials in systemic lupus erythematosus in Korea

[by Kang, In Hyo] Curocell, a company specializing in chimeric antigen receptor T-cell (CAR-T) therapy, announced on August 1 that it has received approval from the Ministry of Food and Drug Safety (MFDS) to initiate a Phase 1/2 clinical trial for its CD19-targeting CAR-T treatment candidate, ‘Anbal-cel (development code CRC01),’ for the treatment of systemic lupus erythematosus (SLE).

With this 꽁 머니 바카라 trial approval, Curocell marks a significant expansion of CAR-T cell therapy applications beyond hematologic malignancies into the field of autoimmune diseases, becoming the first company in Korea to initiate a 꽁 머니 바카라 trial of a CAR-T therapy for an autoimmune condition.

This open-label, single-arm, multi-center Phase 1/2 꽁 머니 바카라 trial will enroll patients with severe systemic lupus erythematosus (SLE) who have demonstrated inadequate response to existing therapies. The Phase 1 portion of the study will primarily assess tolerability and initial safety, while the Phase 2 trial will explore preliminary efficacy outcomes. The trial is expected to be conducted at multiple institutions, beginning with Seoul St. Mary's Hospital of the Catholic University of Korea.

While CAR-T therapies have traditionally been employed in the treatment of hematologic malignancies, they are increasingly gaining attention as a promising therapeutic option for severe autoimmune diseases, particularly in the United States and Europe. SLE is a chronic autoimmune disorder characterized by the immune system’s attack on healthy tissues. In cases of severe disease, some patients exhibit resistance to conventional immunosuppressive therapies, resulting in a significant therapeutic gap. CAR-T cell therapy offers the potential to fundamentally reset abnormal immune responses through a single administration, presenting an innovative treatment alternative for patients burdened by repeated treatments and often ineffective therapeutic regimens.

In March, Professor Ju Ji-Hyeon of Seoul St. Mary's Hospital received approval under Korea’s ‘Therapeutic Use of Investigational Drugs’ program to administer Anbal-cel to a patient with severe SLE who had not responded to conventional treatments. Following treatment, the patient was able to discontinue immunosuppressants without experiencing acute adverse effects while maintaining stable disease parameters. Ultimately, the patient achieved complete clinical remission, enabling the resumption of daily life. This case marks the first application of CAR-T therapy for an autoimmune disease in Korea and is regarded as a significant precedent underscoring the therapeutic potential of this treatment.

"This IND approval represents a significant milestone for Anbal-cel, as it extends the application beyond hematological malignancies to the treatment of autoimmune diseases. We are hopeful that the successful execution of this clinical trial will provide new therapeutic hope for patients with severe SLE who currently face limited treatment options," said Kim Gun-soo, CEO of Curocell.

Conversely, Anbal-cel has successfully completed a Phase 2 꽁 머니 바카라 trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (LBCL) and is currently under regulatory review by the Ministry of Food and Drug Safety. With the recent approval of the SLE 꽁 머니 바카라 trial, Curocell is accelerating its expansion of its therapeutic indications and development pipeline, further solidifying its position as Korea's first commercial developer of CAR-T cell therapies.