CERo Therapeutics Advances Phase 1 Study of CER-1236 for Acute Myeloid Leukemia with Dose Intensification

CERo Therapeutics has increased the dose of CER-1236 in a Phase 1 trial for acute myeloid leukemia (AML). The move follows initial pharmacokinetic data showing cell expansion. The change will double the cell product infused in each subject relative to the previous protocol. The trial's investigator presented a poster outlining the study protocol at the Society of Hematologic Oncology conference. CERo CEO Chris Ehrlich believes the enhanced protocol will provide valuable information on dosing, safety, and feasibility as the study progresses.

CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) has announced a significant update in its Phase 1 clinical trial for acute myeloid leukemia (AML) involving its lead product candidate, CER-1236. The company has increased the dose of CER-1236 in the trial, following initial pharmacokinetic data that showed cell expansion. This dose intensification will double the cell product infused in each subject relative to the previous protocol [1].

The decision to enhance the protocol was made following a review of the initial pharmacokinetic data from the first two enrolled patients by the study's Institutional Review Board (IRB). The modification will allow the evaluation of the feasibility and safety of administering multiple infusions of CER-1236 in patients with AML, as well as assess the implications of increased dosing in this Phase 1 study [1].

The trial's investigator, Abhishek Maiti, M.D., presented a poster outlining the study protocol at the Society of Hematologic Oncology's 13th annual meeting in Houston, Texas. The poster, titled "First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-l in acute myeloid leukemia (CertainT-1)," was presented on September 3, 2025, at the George R. Brown Convention Center [1].

CERo CEO Chris Ehrlich stated, "This has been an important week for CERo, as the enhancement to our Phase 1 protocol for CER-1236 represents meaningful progress in our clinical development efforts. As we closely monitor the second patient in Cohort 1 following their second dose, we are also preparing to enroll the third patient in the cohort. We expect that this protocol adjustment will provide valuable information regarding dosing, safety, and feasibility as we advance toward completion of the cohort" [1].

The first-in-human, multi-center, open-label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with AML that is either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine the highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy [1].

References:
[1] https://www.stocktitan.net/news/CERO/ce-ro-therapeutics-announces-dose-intensification-in-phase-1-study-iylf4k7j6vl0.html