Not about if -28 May 2026 09:54
I get the feeling that certain posters talk about DL2 as though Hemogenyx is still asking the same question it was asking before the first patient was dosed. It isn't. First in human is where the biggest unknowns sit: Will the CAR-T expand, will it cause unexpected toxicity, will it damage normal bone marrow & will it show any biological activity at all? DL1 has already answered a large part of that question. The initial cohort appears to have shown that HG-CT-1 can be administered safely- without dose limiting toxicity and without prolonged cytopenias that would have raised concerns about FLT3 as a target. If deep anti-Leukaemic activity was also observes (ie undetectable leukaemic blasts) then DL1 was not just a safety cohort in practical terms - It was proof that the construct can operate inside a therapeutic window. That makes DL2 a very different proposition from the original first in human leap. DL2 is not asking whether the whole idea is biologically plausible - it is asking whther the signal seen in DL1 can be replicated and potentially strengthened at the next dose level. That is materially lower risk question than the first ever patient treated because the program now has real human data: safety, tolerability, expansion kinetics, marrow behaviour, blast kinetics and early response markers. There is also an important learning component that I am not sure is understood: By following the DL1 patients, the team will have learned a great deal about which biomarkers matter that information should help to interpret and optimise DL2 and paediatric recruitment. It isn't blind repetition - its informed escalation.
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