[Edaily Reporter KIM SUNG-JIN ] "SynKIR-310," a next-generation CAR-T therapy currently under development by Verismo Therapeutics, a U.S. subsidiary of H HLB innoVation(024850), has shown efficacy in early-stage clinical trials. Since no cases of cytokine release syndrome (CRS) or neurotoxicity (ICANS)—common side effects of CAR-T therapy—have been reported, attention is now focused on future clinical results.

HLB innoVation announced on the 5th that Verismo disclosed interim results from the Phase 1 clinical trial “CELESTIAL-301” for SynKIR-310 via an official abstract for the American Society of Hematology (ASH 2026) on the 4th (local time). The study results are scheduled to be presented orally at ASH 2026, which will be held in New Orleans, USA, for four days starting December 12.

SynKIR-310 is a CAR-T therapy that targets the CD19 protein on the surface of cancer cells. A Phase 1 clinical trial is currently underway in patients with relapsed or refractory B-cell non-Hodgkin lymphoma who have received at least two prior lines of treatment.

According to the published abstract, four out of five evaluable patients in the first and second dose cohorts showed a treatment response, resulting in an objective response rate (ORR) of 80%. Among them, three patients achieved a complete response (CR), in which no signs of cancer were detected in tests, bringing the complete response rate to 60%. The median duration of response for patients who achieved a complete response has not yet been reached. One patient was confirmed to have maintained a complete response even 12 months after treatment.

Positive preliminary results were also observed regarding safety. No cases of cytokine release syndrome (CRS) or immune-related adverse events (ICANs) were reported in any of the six patients treated in the first two dose groups. No dose-limiting toxicities (DLTs) were observed. Of these patients, three received the treatment on an outpatient basis without hospitalization.

The doses administered in the first two dose groups fall within the range approved by the U.S. Food and Drug Administration (FDA) for existing CAR-T therapies. Based on these initial safety results, Verismo is currently administering the treatment to patients in the third dose group. The latest clinical results, including data from the third dose group, as well as pharmacokinetic and pharmacodynamic (PK/PD) analysis data, are scheduled to be presented at this conference.

Although CAR-T has garnered attention as a “miracle therapy” due to its outstanding anti-cancer efficacy, serious side effects have been observed in some clinical trials, making safety the primary concern. In particular, these side effects are known to be more severe in solid tumors than in blood cancers. HLB INC. identifies CAR-T therapies as the candidate with the greatest potential among its pipeline.

Brian Kim, CEO and co-founder of Berismo Therapeutics, stated, “KIR-CAR is a proprietary platform technology designed to separate cancer cell recognition from T-cell activation signals, thereby reducing excessive immune responses and premature T-cell exhaustion—the limitations of existing CAR-T therapies,” and “Based on the initial antitumor activity and safety results confirmed in this clinical trial, we will continue to validate the clinical potential of the KIR-CAR platform in the fields of blood cancers and solid tumors,” he said.