Curocell is expanding the indications for its groundbreaking domestic CAR-T therapy RIMQARTO to include second-line treatment. After securing approval as a third-line treatment earlier this year, the company aims to broaden patient access by moving up the treatment timeline.
On October 30, Curocell announced its submission of a request to the Ministry of Food and Drug Safety to modify the clinical trial plan (IND) for RIMQARTO. This modification seeks to extend its use as a second-line treatment for relapsed or refractory adult diffuse large B-cell lymphoma (DLBCL).
The clinical trial will be a multicenter, randomized study comparing RIMQARTO to standard care in patients who have not responded to initial therapy. Leading medical institutions across South Korea, including Samsung Medical Center, will participate. The trial will assess efficacy and safety primarily through event-free survival (EFS) rates.
Current second-line standard treatments, such as salvage chemotherapy and autologous stem cell transplantation, have shown limited effectiveness in DLBCL patients who are refractory to first-line treatment or experience early relapse. Many patients, particularly older individuals or those with comorbidities, face challenges with transplantation. In response, the global medical community is shifting towards earlier application of CAR-T therapies for these patient groups.
Through this trial, Curocell aims to expand RIMQARTO’s treatment scope from third-line and beyond to second-line therapy. The company plans to launch the full-scale trial in the first half of 2027, pending IND approval from regulators.
RIMQARTO leverages Curocell’s proprietary next-generation CAR-T platform, OVIS. This innovative therapy is engineered to simultaneously reduce the expression of PD-1 and TIGIT, immune-suppressing factors in CAR-T cells, enabling sustained anti-tumor activity even within the challenging tumor microenvironment.
Earlier this year, Curocell received regulatory approval for RIMQARTO as a third-line treatment for relapsed or refractory adult DLBCL. The company is currently navigating the health insurance reimbursement process, with the goal of securing coverage and initiating commercial treatment by year-end.
Curocell Chief Executive Officer (CEO) Kim Geon-soo emphasized that this Phase 3 IND application marks a crucial step in expanding RIMQARTO’s reach beyond third-line treatment to earlier stages of care. The goal is to launch the comprehensive Phase 3 trial by early 2027, offering faster access to CAR-T therapy for patients who need alternatives after first-line treatment failure.
CAR-T therapy represents a breakthrough in personalized medicine. The process involves extracting a patient’s T-cells, genetically modifying them to target cancer cells, and reinfusing them back into the patient. This cutting-edge approach offers new hope for blood cancer patients who have exhausted traditional treatment options or experienced relapse.
