CERo Therapeutics has announced that Colorado Blood Cancer Institute’s (CBCI) Sarah Cannon Research Institute (SCRI), US, will be the main site for its Phase I study evaluating CER-1236 to treat acute myeloid leukaemia (AML).
Subject enrolment is ongoing for the first-in-human trial, and the initial subject cohort dosing is anticipated by this June.
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The Phase I/Ib open-label, multi-centre trial is structured to assess the preliminary efficacy and safety of the therapy in individuals with relapsed/refractory AML and measurable residual disease, or who carry a tumour protein p53 (TP53) gene mutation.
It will consist of two parts: a dose escalation phase for determining the highest tolerated dose and a recommended Phase II dose, with a subsequent expansion phase to assess efficacy and safety.
The trial’s primary outcome measures are monitoring the incidence of adverse and serious adverse events (SAEs), dose-limited toxicities, and estimating complete response (CR), composite complete response (cCR), measurable residual disease (MRD), and overall response rate (ORR).
Secondary outcome measures will focus on pharmacokinetics.
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By GlobalDataCERo is planning to commence trials of CER-1236 for haematological malignancies this year.
CERo Therapeutics CEO Chris Ehrlich said: “CBCI is a world-renowned cancer centre, and we believe their participation in our AML trial is continued validation of the scientific work performed to date with CER-1236. We look forward to announcing enrolment and initial dosing in the near term for this trial and to progress in launching our solid tumour study.”
The company develops engineered T-cell therapeutics for cancer treatment. Its approach to engineering the T-cells combines aspects of innate and adaptive immunity into one therapeutic construct, aiming to use the body’s complete immune repertoire for cancer therapy.
