HLB Innovation announced on July 23 that its U.S. subsidiary, Verismo Therapeutics, has expanded the Phase 1 clinical trial for SynKIR-310—a next-generation chimeric antigen receptor T-cell (CAR-T) therapy candidate for blood cancers—to evaluate safety and tolerability at higher dose levels.
Verismo recently initiated recruitment and enrollment for Cohort 3 of the study. The multicenter U.S. trial is evaluating SynKIR-310 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The trial population includes both CAR-T-naive patients and individuals whose disease relapsed after receiving prior CD19-targeted CAR-T therapies.
Expanding dosage cohorts following FDA consultation
The study was originally designed to escalate doses across two patient groups, Cohort 1 and Cohort 2. Dose-limiting toxicity (DLT) refers to side effects severe enough to prevent further dose increases. After observing no DLTs through Cohort 2, Verismo consulted with the U.S. Food and Drug Administration (FDA) to revise the trial protocol, adding Cohorts 3 and 4.
Cohort 3 will evaluate dose levels exceeding those typically used with current commercial CAR-T products. Results from Cohorts 3 and 4 will be used to establish the recommended Phase 2 dose for subsequent clinical trials.
Mitigating immunotoxicity with KIR-CAR technology
In conventional CAR-T therapies, higher doses frequently increase the risk of severe side effects, such as cytokine release syndrome (CRS) and neurotoxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). A primary objective of the expanded trial is to confirm whether SynKIR-310 can maintain its safety profile at elevated dose levels.
SynKIR-310 utilizes Verismo's proprietary KIR-CAR platform. Modeled after natural killer cell biology, the multi-chain architecture is designed to prevent excessive T-cell activation when no target antigen is present, aiming to reduce immunotoxicity and prevent chronic T-cell exhaustion.
Verismo plans to present interim Phase 1 data through Cohort 2 at an international academic conference later this year. Previously, at the American Association for Cancer Research annual meeting (AACR 2026) in April, the company presented a case study of a patient in their 70s with follicular lymphoma enrolled in Cohort 1. The patient achieved a complete response 28 days post-infusion without experiencing severe CRS or ICANS, maintaining that complete response for more than six months.
An official from HLB Innovation noted that growing interest among clinicians and patients following the release of early clinical data has further accelerated recruitment for the trial.
