HLB Innovation Expands CAR-T Dose Range in Blood Cancer Clinical Trial
HLB Innovation has expanded the cohort in the U.S. Phase 1 clinical trial (CELESTIAL-301) of its next-generation blood cancer CAR-T candidate, SynKIR-310.
According to HLB Innovation on July 23, its U.S. subsidiary, Verismo Therapeutics, has recently initiated full-scale patient enrollment for cohort 3 in the SynKIR-310 Phase 1 trial. CELESTIAL-301 is an open-label, multi-center U.S. clinical study targeting patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). Notably, the enrollment criteria include patients who have relapsed even after treatment with already commercialized CD19 CAR-T therapies, thereby assessing the therapeutic potential of SynKIR-310 in a patient population with extremely limited treatment options.
The trial was originally designed with two dose-escalation steps, taking into account the typical dose range of commercially available CAR-T therapies. However, after confirming favorable tolerability—such as the absence of dose-limiting toxicity (DLT) in cohort 2—the company held discussions with the U.S. Food and Drug Administration (FDA) and has now expanded the dose-escalation phase by two additional steps, up to cohort 4.
The newly entered cohort 3 involves a high-dose range that exceeds the standard dosing levels of existing commercial CAR-T therapies. Through this, the company aims to once again demonstrate SynKIR-310’s potential to surpass the safety profile of existing CAR-T therapies via the unique on/off mechanism of its multi-chain KIR-CAR platform and to secure clear clinical evidence for determining the recommended Phase 2 dose (RP2D).
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An HLB Innovation representative stated, "Following the release of early clinical data, healthcare professionals and patients have shown increasing interest in SynKIR-310, accelerating patient enrollment. We plan to continue the clinical trial without interruption to prove both safety and therapeutic efficacy at higher dose levels, and to continuously build clinical evidence supporting the differentiated value of Verismo’s KIR-CAR platform."
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