CERo Therapeutics Presents Positive Phase 1 Data for Leukemia Treatment

Interim results from CERTAIN-T trial show rapid cell expansion and platelet transfusion independence in high-risk MDS/AML patient

Published on Feb. 4, 2026

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CERo Therapeutics, an innovative cellular immunotherapy company, announced the presentation of positive interim data from the Phase 1 CERTAIN-T trial of its lead compound CER-1236. The data highlight a favorable safety and tolerability profile, rapid in vivo cell expansion, and an index patient with acute myeloid leukemia (AML) who progressed from myelodysplastic syndrome (MDS) and achieved platelet transfusion independence after treatment.

Why it matters

The early clinical findings for CER-1236 demonstrate its potential as a first-in-class TIM-4L-targeting cell therapy for myeloid diseases like AML and MDS, which are often difficult to treat. Achieving transfusion independence is an important milestone for patients, as it can improve quality of life and reduce the burden of frequent medical procedures.

The details

The CERTAIN-T trial is a first-in-human, multi-center, open-label Phase 1/1b study evaluating the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory AML, AML in remission with measurable residual disease, or newly diagnosed TP53 mutated AML. The trial has recently been amended to also include transfusion-dependent MDS, high-risk MDS, and post-JAK-inhibitor myelofibrosis. In the first cohort, CER-1236 demonstrated a favorable safety profile with no dose-limiting toxicities, cytokine release syndrome, or immune effector cell-associated neurotoxicity syndrome. The index patient with AML progressed from MDS received four CER-1236 infusions over 5 months at the lowest dose level and achieved platelet transfusion independence lasting over two months.

  • The CERTAIN-T trial was initiated in 2025.
  • The first cohort data is being presented at the Tandem Meeting of the ASTCT and CIBMTR on February 5, 2026.
  • The second cohort of the CERTAIN-T trial is now underway with ongoing enrollment.

The players

CERo Therapeutics Holdings, Inc.

An innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer.

Robert Sikorski, M.D., Ph.D.

CERo Therapeutics Chief Medical Officer.

Chris Ehrlich

CERo Therapeutics CEO.

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What they’re saying

“CER-1236 is a first-in-class TIM-4L–targeting cell therapy with early clinical findings demonstrating a favorable safety and tolerability profile to date with no dose-limiting toxicities and no observed cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in the first four treated patients. These early observations support continued clinical evaluation of CER-1236 in myeloid disease settings.”

— Robert Sikorski, M.D., Ph.D., CERo Therapeutics Chief Medical Officer (Globe Newswire)

“The acceptance of this late-breaking abstract by an independent review committee highlights the scientific interest in CER-1236 and the progress of the program. While CER-1236 has demonstrated broad potential across multiple tumor types in preclinical studies, the emergence of early clinical observations in AML and MDS underscores the relevance of this approach in myeloid disease settings. The Company continues to advance the CERTAIN-T trial, with the second cohort now underway and enrollment ongoing. We remain focused on the careful and deliberate execution of the dose-escalation phase and the systematic collection of safety data, and we look forward to sharing additional updates with regulatory authorities and other stakeholders as the study progresses.”

— Chris Ehrlich, CERo Therapeutics CEO (Globe Newswire)

What’s next

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The takeaway

The positive interim results for CER-1236 in the CERTAIN-T trial, including the achievement of platelet transfusion independence in a high-risk MDS/AML patient, suggest this novel cellular immunotherapy approach may offer a promising new treatment option for patients with myeloid malignancies who currently have limited therapeutic options.