CERo Therapeutics has initiated the second cohort of its Phase I clinical trial of CER-1236 for the treatment of acute myeloid leukaemia (AML).
The first participant in this cohort received a dose twice that of the initial cohort, followed by a second identical dose 48 hours later.
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The two-part, open-label, first-in-human, multi-centre Phase I/Ib trial is evaluating the preliminary and safety efficacy of CER-1236 in participants who are either relapsed or refractory, in remission with measurable residual disease, or those newly diagnosed with TP53 mutated myelodysplastic syndrome (MDS).
It involves dose escalation to identify the highest tolerated dose for Phase II, followed by an expansion phase to further assess efficacy and safety.
Primary outcomes include complete response (CR), incidence of serious adverse events (SAEs) and adverse events (AEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), measurable residual disease (MRD), and composite complete response (cCR).
Secondary outcomes of the trial include pharmacokinetics (PK).
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By GlobalDataCERo CEO Chris Ehrlich said: “We remain encouraged by the progress and results of our ongoing Phase I trial of CER-1236 given the safety data and cell expansion seen to date.
“The safety results observed thus far in the trial, which have included those recorded from subsequent dosing following the initial doses, have guided the strategy to significantly increase the dosing in this cohort, which we believe will be very instructive as we continue to determine a Phase II dose.
“In the meantime, we wish to emphasise that CERo remains focused on the development of CER-1236 and remains open for business as we evaluate the best way to move forward with regard to our stock being listed on a public exchange.”
The company previously noted that the third participant in the initial cohort would be administered a second dose of CER-1236.
Investigators decided not to administer that additional dose based on the patient’s disease progress, and the study has now advanced to increased dosing in the second cohort.
Last month, CERo completed the first cohort of its Phase I study of CER-1236 involving participants diagnosed with AML.
