Three (3) of 4 patients dosed at 2×105 anbal-cel cells/kg have documented complete remission, and 2 responder patients maintain complete remission for more than a year. Surprisingly, all patients received 2×106 cells/kg reported complete remission after a single dose of anbal-cel.
The complete results of the phase 1 study were presented to EHA during the EHA (European Hematology Association) congress, Vienna, Austria, 09-17 June 2022.
The anbal-cel is the CD19 CAR-T built into the OVISMT (Overcoming Immune Suppression). OVISMT The technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells.
“Although CD19-directed CAR-T therapy has changed the treatment paradigm for large B-cell lymphoma, which is one of the most aggressive malignant hematological cancers, more than 50% of patients with LBCL do not have benefited from the clinical benefits of CD19 CAR-T treatment, and there are still huge unmet medical needs Anbal-cel Phase 1 study result demonstrates the OVISMT potential of the platform to maximize the functionality of CAR-T to eradicate tumors. We are very excited about this promising clinical result even though the number of patients treated with anbal-cel is limited with a total of 11 and look forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Additionally, we believe this data represents the excellence of our next-generation CAR-T technology.” Gunso KimCEO of Curocell.
This phase 1 study aimed to evaluate safety and preliminary efficacy in patients with r/rLBCL. The patient received a single intravenous infusion of 2×105 cells/kg (dose level 1), 7×105 cells/kg (DL2) or 2×106 cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to anbal-cel infusion.
Eleven (11) patients with r/r DLBCL received anbal-cel infusion. All patients received at least two prior lines of therapy and 36% (4/11) received ≥4 prior lines of therapy prior to the study. No patient presented with DLT during the study.
Of the 11 patients, 5 (46%) patients presented with CRS; 3 (27%) were grade 1 or 2 and 2 (18%) had grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19).
One patient received 2×106 cells/kg ICANS grade 2 experienced; ICANS onset time was 7 days and lasted 13 days. This patient had a history of CNS involvement prior to the study. Commonly reported Grade 3/4 treatment-related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS ( 2/11, 18%). .
Dose dependent CRC01 an expansion was observed; median Tmaximum was 15.4, 15.8 and 14.5 days at DL1, DL2 and DL3 each; VSmaximumCSA0-28 day was proportionally increased.
Based on the promising safety and efficacy data from the Phase 1 study, the Phase 2 trial has been initiated and patient recruitment is underway.
The details of the oral presentation to EHA are as follows:
Submission ID: EHA-3438
Title: PHASE 1/2 STUDY OF ANBAL-CEL, NEW ANTI-CD19 CAR-T THERAPY WITH DOUBLE SILENCING OF PD-1 AND TIGIT IN REFAULT OR REFRACTORY LARGE B-CELL LYMPHOMA
Session title: Aggressive lymphoma – CART
Date and time of the session: Saturday June 11 11:30 – 12:45
Session room: Room A7
Final abstract code: S214
About anbalcabtagene autoleucel (anbal-cel)
Anbal-cel, recognized CD19 and based on OVISMT, a first-class CAR-T platform. OVISMT the technology downregulates the expression of PD1 and TIGIT in CAR-T cells. By overcoming immune suppression by PD-L1 and TIGIT ligands, OVISMT CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. anbal-cel’s phase 2 clinical trial began in South Korea in the first half of 2022.
About Curocell, Inc.
Curocell, based in Daejeon, South Korea, is an innovative biotech in the clinical stage of CAR-T therapies. Curocell develops OVISMT technology to improve the clinical effectiveness of CAR-T therapies. For more information, visit www.curocellbtx.com/en.