CERo Flags Early Safety Signals for CER-1236 in First-in-Human AML Study
Early-stage cell therapy trials rarely offer headline-grabbing certainty, but they can provide something almost as valuable: a clean safety read that justifies pressing on.
That is the tone set by new findings from CERo’s ongoing phase 1 CertainT-1 study, which is evaluating CER-1236, a first-in-human chimeric engulfment receptor (CER) T-cell therapy in patients with acute myeloid leukaemia (AML).
Investigators have now completed the dose-limiting toxicity (DLT) observation period in the first cohort and reported cell expansion without the complications that often dominate early discussions around engineered T-cell approaches.
According to the update, the first cohort has so far shown no cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), and no treatment-related adverse events.
While longer follow-up and additional patients will be required before drawing meaningful conclusions, the absence of these early red flags is being presented as an encouraging safety signal – particularly in AML, where effective and tolerable immune-based options have historically been harder to translate than in some other blood cancers.
Beyond the “no news is good news” safety snapshot, investigators also highlighted a notable clinical observation in a second patient whose myelodysplastic syndrome (MDS) had progressed to AML.
Following treatment with CER-1236, the patient experienced a 61-day platelet transfusion-free interval. That matters because platelet transfusion independence is commonly used as a meaningful benchmark in studies assessing supportive-care improvements, and the reported interval surpasses the frequently referenced eight-week (56-day) threshold.
Importantly, the achievement was recorded in a patient described as having advanced disease, including an inv3 chromosomal abnormality – a feature often associated with higher-risk disease biology and more limited treatment responsiveness.
The company’s response to this early data has been to widen the net. CERo has amended the CertainT-1 protocol to expand enrollment beyond AML, bringing advanced MDS and myelofibrosis into scope.
Strategically, that move broadens the potential clinical relevance of the platform by testing the therapy across a wider spectrum of myeloid conditions that share unmet need, while still allowing the trial to build a systematic picture of safety and early signs of activity as dose escalation continues.
Underpinning the programme is the company’s positioning of CER-1236 as something more than a conventional CAR-T variant. The therapy has been engineered to combine features of both adaptive and innate immunity, integrating traditional cytotoxic T-cell activity with phagocytic engulfment mechanisms.
In principle, this hybrid design is intended to tackle limitations that conventional CAR-T therapies have faced in myeloid malignancies – diseases where tumour biology, antigen complexity, and the surrounding cellular environment can make durable targeting more difficult than in better-established CAR-T settings.
For now, the story remains firmly in the early but intriguing category. The reported completion of the DLT window in the first cohort, the clean early safety profile, and the platelet transfusion-free interval in a high-risk patient provide CERo with momentum heading into continued dose escalation and broader enrollment.
The next chapters will depend on whether these initial signals hold up across more patients – and whether safety, expansion, and early efficacy continue to align as the study explores the therapy’s potential across AML, advanced MDS, and myelofibrosis.
Conclusion
In its phase 1 CertainT-1 study, CERo has reported an encouraging early safety readout for CER-1236 in AML, including completion of the first cohort’s DLT observation period with cell expansion and no CRS, no ICANS, and no treatment-related adverse events to date.
A standout clinical observation – 61 days without platelet transfusions in a patient whose MDS progressed to AML, despite advanced features such as an inv3 abnormality – adds further interest, prompting an amendment to expand enrolment to advanced MDS and myelofibrosis.
With dosing still escalating, the coming data will determine whether CER-1236’s adaptive-plus-innate engineering concept can translate into a broader, durable treatment opportunity in myeloid disease.
News Credits: CERo reports encouraging early data from phase 1 trial of CER‑1236
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