CERo has released new findings from its ongoing phase 1 CertainT‑1 study evaluating CER‑1236, a first‑in‑human chimeric engulfment receptor T‑cell therapy being tested in patients with acute myeloid leukaemia.
Investigators have completed the dose‑limiting toxicity observation period in the first cohort and reported cell expansion with no cytokine release syndrome, no ICANS and no treatment‑related adverse events so far, marking a positive early safety indication for an engineered T‑cell approach in AML.
A notable observation was recorded in a second patient whose myelodysplastic syndrome had progressed to AML. Investigators reported a 61‑day platelet transfusion‑free interval after treatment with CER‑1236, surpassing the commonly referenced eight‑week benchmark used in studies assessing platelet transfusion independence.
The result was achieved in a patient with advanced disease, including an inv3 chromosomal abnormality.
In response to these early findings, CERo has amended the CertainT‑1 protocol to widen enrolment beyond AML to include advanced MDS and myelofibrosis, a move that broadens the potential clinical relevance of the platform. The company continues to escalate dosing while gathering systematic safety and early efficacy data.
CER‑1236 has been engineered to combine features of both adaptive and innate immunity.
The therapy integrates traditional cytotoxic T‑cell activity with phagocytic engulfment mechanisms, an approach CERo believes may help address limitations associated with conventional CAR‑T therapies in myeloid malignancies.
