CHM chimeric therapeutics limited

Reading the details and trying to puzzle together what is also...

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    Reading the details and trying to puzzle together what is also written between the lines:

    • The trial overall is looking for "Enrollment (Estimated) 32 " across dose escalation and dose expansion cohorts.
    • Company presentations mention 3 different dosage levels (50, 150 & 450).
    • We have been told that the dose expansion part has completed on 24 October 2024.
    • Same announcement now mentions that the frontline dose expansion part will open soon, looking to enrol 20 patients.
    • The latest presentation did not tick the Frontline part in the 2024 Deliverables.
    • The Ash publication in November 2023 mentioned the following trial design, "Trial design: The dose escalation phase will enroll a maximum of 12 patients at 2 dose levels to establish a recommended phase 2 dose (RP2D) using a BOIN design. The dose expansion will enroll up to 20 patients at the RP2D ( Fig. 1)."

    From the above, I'm drawing the following conclusions:

    1. We have already enrolled at least 8 patients (presentation I posted mentions 3/3 & 5/5), but likely even more patients (up to 12).
    2. The recruitment of these 3 (dose escalation) cohorts is due to be released soon since enrolment completed end of Octover 2024.
    3. Since Frontline has not been ticked, is the final cohort of the trial and there was no chance to see 20 patients enrolled in that cohort between 24/10/24 and 31/12/24, it must related to the first patient dosed in that final cohort.
    4. The first part of the trial is not specific to elderly and/or unfit and newly diagnosed, since the trial design on clinicaltrials.gov has a few extra criteria for the dose expansion cohorts (only, not for the escalation cohort), "Dose expansion cohort: Dose expansion cohort will only enroll older/unfit patients with newly diagnosed adverse or intermediate risk AML or MDS/AML who are ineligible for intensive chemotherapy and/or are ineligible for or decline to receive allo-SCT (please refer to stratification in statistics section). [...]"

    There is plenty of potential here in the data of the first up to 12 patients already and we should soon find out if my assumptions are correct.
    Last edited by pfeifer1982: 15/12/24
 
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