Rimqarto (anbalcabtagene autoleucel) / Curocell - LARVOL DELTA

Anbalcabtagene Autoleucel: First Approval. (PubMed, Mol Diagn Ther) - "for the treatment of diffuse large B-cell lymphoma, acute lymphoblastic leukaemia and autoimmune diseases, which received its first approval in April 2026 in South Korea. This article summarizes the milestones in the development of anbalcabtagene autoleucel leading to this first approval for the treatment of relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma in adults following ≥ 2 lines of systemic therapy."

Journal • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • PD-1 • TIGIT

Anbalcabtagene autoleucel (PD-1 and TIGIT knockdown CD19 CAR-T) for relapsed/refractory large B-cell lymphoma (CRC01-01). (PubMed, Blood) - P1/2 | "Serious infections occurred in 25.3% of patients, and grade 5 infection was reported in 3 patients. This trial was registered at Clinicaltrials.gov (NCT04836507)."

IO biomarker • Journal • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • PD-1 • TIGIT

Korea clears RIMQARTO for conditional coverage… (Chosun Biz) - "However, the decision came with the condition that Curocell must accept the proposed assessment price. If the company accepts, the process will move to price negotiations with the National Health Insurance Service and a resolution by the Health Insurance Policy Deliberation Committee (HIPDC)....RIMQARTO is indicated for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed after two or more lines of systemic therapy or are refractory to treatment."

Reimbursement • Diffuse Large B Cell Lymphoma • Mediastinal B Cell Lymphoma

Curocell's CAR-T therapy Rimqarto clears 1st reimbursement hurdle in Korea (Korea Biomedical Review) - "The company said Thursday that the Health Insurance Review and Assessment Service's (HIRA) Cancer Disease Review Committee (CDRC) determined at its sixth meeting on Wednesday that reimbursement criteria could be established for Rimqarto. The decision follows the therapy's marketing approval in April and moves the treatment closer to reimbursement and commercial launch in Korea.....A positive recommendation allows the reimbursement process to proceed to subsequent stages, including price negotiations and final listing under the national health insurance system....Rimqarto is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy." "

Reimbursement • Diffuse Large B Cell Lymphoma

Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients (clinicaltrials.gov) - P1/2 | N=91 | Recruiting | Sponsor: Curocell Inc. | Trial completion date: Feb 2028 ➔ Sep 2030 | Trial primary completion date: May 2023 ➔ Aug 2030

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

Curocell reports published phase 2 results for approved CAR-T therapy (Korea Biomedical Review) - "According to the paper, Rimqarto achieved an objective response rate (ORR) of 75.3 percent and a complete response (CR) rate of 67.1 percent based on assessments conducted by an Independent Review Committee (IRC)...In terms of safety, the incidence of Grade 3 or higher cytokine release syndrome (CRS) was 8.9 percent, while the rate of neurotoxicity (NE) was 3.8 percent...The company said it plans to use the publication to support global business development activities, including overseas clinical development and licensing discussions. Curocell is also developing CAR-T therapies for solid tumors and other next-generation cell and gene therapy platforms."

Cytokine release syndrome • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • High-grade B-cell lymphoma • Large B Cell Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

Curocell to retry CAR-T Rimqarto reimbursement in July after first HIRA setback (Korea Biomedical Review) - "The Health Insurance Review and Assessment Service (HIRA) said Wednesday that the 2026 5th Cancer Disease Review Committee did not set reimbursement criteria for Rimqarto (anbalcabtagene autoleucel), Curocell’s autologous CD19-targeting CAR-T therapy for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy."

Reimbursement • Diffuse Large B Cell Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

The Ministery of Food and Drug Safety said on the 29th it approved Korea’s first CAR-T therapy, “Rimqarto“ (development name Anbalcel), developed by Curocell. (Chosun Biz) - "It targets patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)....In its phase 2 trial's final readout, Rimqarto was shown to be more effective than six FDA-approved therapies. Its complete response (CR) rate—the share of patients whose cancer disappeared completely—was 67.1%, higher than Kymriah (40%), Breyanzi (53%), and Yescarta (54%)....Curocell plans to seek approval from the U.S. Food and Drug Administration (FDA) next."

Korea approval • Diffuse Large B Cell Lymphoma

Curocell's Rimqarto achieves 1st confirmed 5-year cure in high-risk lymphoma (Korea Biomedical Review) - "The phase 1 trial was conducted on patients with recurrent or refractory large B-cell lymphoma (LBCL), a condition with limited treatment options and a poor prognosis. The cured patient has maintained normal daily life without disease recurrence or progression since receiving treatment. The promising results come after Curocell transitioned the first group of patients in the phase 1 trial into a long-term follow-up stage. The transition follows the completion of the formal five-year observation period for the initial participants."

P1 data • Large B Cell Lymphoma

CRC01-02: Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=39 | Not yet recruiting | Sponsor: Curocell Inc.

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

Curocell nears approval for Korea's first CAR-T and readies commercialization (Chosun Biz) - "Rimqarto (development name Anbalsel)...is awaiting a Ministery of Food and Drug Safety approval decision in the first quarter of this year....If approval is granted, a fast-track process will apply through listing for national health insurance reimbursement and price negotiations, leading to a potential launch as early as the second quarter and revenue starting in the second half, according to projections....Rimqarto is a CAR-T cell therapy indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)....Curocell submitted a marketing authorization application for Rimqarto to the Ministery of Food and Drug Safety on Dec. 30, 2024."

Korea approval • Launch non-US • Reimbursement • Diffuse Large B Cell Lymphoma

Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Hyungwoo Cho | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

Gut Microbiome Composition As a Prognostic Marker in CD19-Targeting CAR T-Cell Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (ASH 2024) - "Methods We analyzed 47 patients with R/R DLBCL who were schedule to undergo anti-CD19 CAR T-cell therapy, including 29 patients receiving tisagenlecleucel (tisa-cel) and 18 receiving anbalcatagene autoleucel (anbal-cel). These findings underscore the potential for microbiome modulation as a strategy to overcome CAR T-cell therapy resistance and improve patient outcomes. We are currently conducting functional studies to explore the interplay between the tumor microenvironment and microbiome."

Biomarker • CAR T-Cell Therapy • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Curocell Signs CAR-T Raw Material Supply Agreement, Accelerating Commercialization of Rimqarto [Google transkation] (HIT News) - "With the Ministry of Food and Drug Safety (MFDS) currently reviewing the product approval process for 'RIMQARTO,' a next-generation CAR-T treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the company explained that it has further strengthened its preemptive establishment of a raw materials and supply chain (SCM) to advance to the commercialization stage."

Commercial • Diffuse Large B Cell Lymphoma

Curocell…said it has received approval from the Ministry of Food and Drug Safety (MFDS) to initiate a phase 2 clinical trial of its investigational CAR-T therapy Anbalcel (CRC01) in adult patients with acute lymphoblastic leukemia (ALL) (Korea Biomedical Review) - "The company plans to begin patient enrollment and commence the trial shortly. The newly approved protocol expands the scope of eligible patients and details specific efficacy evaluation methods."

New P2 trial • Acute Lymphocytic Leukemia

A Pilot Study of Anbalcabtagene Autoleucel (Anbal-Cel) in Patients with Relapsed or Refractory Primary or Secondary Central Nervous System Lymphoma (ICBMT 2025) - "Anbalcabtagene autoleucel (Anbal-cel) is a novel second-generation anti-CD19 CAR T-cell product currently under investigation in systemic DLBCL...Following leukapheresis, patients will undergo lymphodepletion with fludarabine and cyclophosphamide for three days, followed by a single intravenous infusion of Anbal-cel at a target dose of 2×10⁶ CAR+ viable T cells/kg... This study is a prospective clinical trial investigating CD19-targeted CAR T-cell therapy in patients with PCNSL or SCNSL using Anbal-cel. Given the poor prognosis and lack of effective salvage options in this population, the study will provide important insights into the safety, feasibility, and potential activity of CAR T-cell therapy in the CNS lymphoma. Keywords: CNS lymphoma, CAR-T"

Clinical • IO biomarker • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

Curocel files IND amendment for Anbalcel for adults with ALL, with the aim of initiating Phase 2 clinical trials. [Google translation] (BioTimes) - "Curocell...announced on the 8th that it has submitted an application for a change to the clinical trial plan (IND) to the Ministry of Food and Drug Safety for the initiation of phase 2 clinical trials of 'Anbalcel (CRC01),' a CAR-T treatment for adult acute lymphoblastic leukemia (ALL). This IND amendment application was submitted to incorporate Phase 1 clinical trial results into the Phase 2 clinical trial design."

New P2 trial • B Acute Lymphoblastic Leukemia

Curocell Receives FDA Approval for Phase 1/2 CAR-T Clinical Trial for SLE [Google translation] (HIT News) - "Curocell...announced on the 1st that the Ministry of Food and Drug Safety approved the phase 1/2 clinical trial plan for systemic lupus erythematosus (SLE) for its CD19-targeting CAR-T treatment 'Anbalcel (CRC01)'....This clinical trial will target patients with severe SLE who have not responded to existing treatments. Phase 1 will evaluate safety and tolerability, while Phase 2 will assess efficacy. Multiple institutions, including Seoul St. Mary's Hospital of the Catholic University of Korea, are expected to participate."

New P1/2 trial • Systemic Lupus Erythematosus

Curocell launches CUROLINK to streamline CAR-T supply chain ahead of Rimqarto rollout (Korea Biomedical Review) - "In advance of the commercialization of its next-generation CAR-T therapy, RIMQARTO, Curocell has developed CUROLINK, an integrated solution that tracks and manages the entire process from prescription to administration in real-time. CUROLINK is a cloud-based cell therapy supply management solution based on a fully licensed Salesforce-based customer relationship management (CRM) platform....Curocell has completed system stabilization and linkage verification and plans to introduce it to major hospitals in Korea in time for the launch of RIMQARTO."

Commercial • Large B Cell Lymphoma

Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Hyungwoo Cho

New P2 trial • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Secondary Central Nervous System Lymphoma

Comparative Effectiveness of Anbalcabtagene Autoleucel versus Tisagenlecleucel in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma. (PubMed, Cancer Res Treat) - "We performed a matching-adjusted indirect comparison (MAIC) using individual patient data from CRC01-01 (NCT#04836507) and aggregate data from JULIET trial (NCT#02445248). After applying MAIC to balance prognostic factors between the groups, adjusted HRs or ORs were 0.47 (0.23-0.95) for OS, 0.59 (0.36-0.96) for PFS, 2.60 (1.04-6.52) for ORR, and 3.00 (1.30-6.92) for CRR. Anbal-cel showed superior effectiveness over tisa-cel, with higher response rates and improved survival outcomes, even after accounting for imbalances in prognostic factors at trial enrollment."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PD-1 • TIGIT

Curocell files IND for Anbal-cel trial in sever lupus (Korea Biomedical Review) - "Curocell on Monday filed an Investigational New Drug (IND) application with the Ministry of Food and Drug Safety (MFDS) for its CD19-targeted CAR-T therapy Anbal-cel (CRC01) in systemic lupus erythematosus (SLE)...The study is an open-label, multicenter, single-arm, phase 1/2 trial to evaluate the tolerability, safety, and efficacy of Anbal-cel in patients with severe SLE who have not responded to existing treatments."

New P1/2 trial • Systemic Lupus Erythematosus

ANBALCABTAGENE AUTOLEUCEL (PD-1 AND TIGIT KNOCKDOWN CD19 CAR-T) FOR RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (CRC01-01) (ICML 2025) - "Lymphodepletion was performed with cyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2, administered for three days (-5, -4, -3 days). Anbal-cel demonstrated PD-1 and TIGIT knockdown can contribute to long-term response with high CR rate and manageable safety profile."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • B3GAT1 • CD38 • ENTPD1 • HAVCR2 • IL7R • PD-1 • TIGIT

Curocell, “Clinical Efficacy and Safety Scientifically Proven” in Final Phase 2 Clinical Trial of ‘anbal-cel’ [Google translation] (BioTimes) - P1/2 | N=91 | NCT04836507 | Sponsor: Curocell Inc. | "A total of 79 patients received anbal-cel, of which 75.3% (55 patients) achieved an objective response rate (ORR) and 67.1% (53 patients) achieved a complete response (CR). The median follow-up period was 8.5 months, and the long-term follow-up results showed that the progression-free survival (PFS) at 12 and 18 months was 41.1% and 35.2%, and the overall survival (OS) was 66.6% and 57.3%, respectively. The median progression-free survival (mPFS) was 6.0 months, which was twice as long as the mPFS (2.9 months) in the Kimria clinical trial."

P2 data • Diffuse Large B Cell Lymphoma

Curocell 'CAR-T', Autoimmune Patient "First Administration.. Positive Initial Response" [Google translation] (Biospectator) - "Curocell announced on the 17th that it recently administered its first CD19 CAR-T 'anbal-cel' to a patient with intractable lupus at the Catholic University of Korea Seoul St. Mary's Hospital. This was conducted based on the Ministry of Food and Drug Safety's therapeutic use approval procedure...According to Curocell, the patient recovered to the point where he could return to his daily life without any acute side effects after administration of Anbalcel, and is showing a positive initial treatment response, such as improvement in lupus-related disease indicators even after discontinuation of immunosuppressants....Curocel plans to submit an Investigational New Drug (IND) application for phase 1/2 clinical trial of Anbalcel targeting patients with systemic lupus erythematosus (SLE) to the Ministry of Food and Drug Safety in the first half of this year."

New P1/2 trial • Trial status • Lupus • Systemic Lupus Erythematosus