HLB Innovation has confirmed the safety of initial dosages in its U.S. Phase 1 clinical trial (CELESTIAL-301) for the next-generation chimeric antigen receptor T-cell (CAR-T) candidate, SynKIR-310. Following discussions with the U.S. Food and Drug Administration (FDA), the company will now verify the safety and therapeutic potential of higher dosage ranges.
CAR-T therapy involves collecting a patient's T-cells, genetically modifying them to recognize cancer cells with a chimeric antigen receptor (CAR), and reinfusing them into the body.
On July 23, HLB Innovation announced that its U.S. subsidiary, Verismo Therapeutics, has begun enrolling patients for Cohort 3 in the Phase 1 trial of SynKIR-310.
CELESTIAL-301 is an open-label, multicenter trial in the U.S. targeting patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). It includes patients who have relapsed after receiving existing CD19 CAR-T therapies, assessing the potential of SynKIR-310 in a patient population with limited treatment options.
The expansion of the trial follows the observation of no dose-limiting toxicities (DLT) in Cohort 2, confirming its tolerability. Originally designed in two phases, the dosage escalation plan has been expanded by two additional phases to Cohort 4 after discussions with the FDA.
Cohort 3 will explore high dosage ranges that exceed the typical administration levels of currently commercialized CAR-T therapies. The company aims to further validate the safety of SynKIR-310, based on the multi-chain KIR-CAR platform, and establish evidence for the recommended Phase 2 dose (RP2D).
Generally, as the dosage of CAR-T therapies increases, the risk of severe side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) also rises. Additionally, high-dose cell administration requires efficient gene transfer into T-cells and maintenance of consistent cell quality, making manufacturing more challenging.
Verismo's KIR-CAR platform applies the operational principles of NK cell KIR receptors to CAR-T technology. It is designed to suppress unnecessary T-cell activation in the absence of target antigens, reducing immunotoxicity and cell exhaustion while allowing for more sustained attacks on cancer cells.
Verismo plans to present interim results from the Phase 1 trial up to Cohort 2 at a global conference later this year.
In April, at the American Association for Cancer Research (AACR 2026), the company reported that a patient in Cohort 1 achieved complete remission (CR) without severe CRS or ICANS just 28 days after treatment, maintaining remission for over six months. This study was selected for an oral presentation in the prestigious 'Plenary' session, marking a first for a domestic company.
An HLB Innovation representative stated, "We will continue to secure clinical evidence supporting the safety and therapeutic efficacy in higher dosage ranges, reinforcing the distinctiveness of the KIR-CAR platform."
* This article has been translated by AI.
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