Fred Hutch Joins CERo Therapeutics Cancer Trial Site

The Seattle center is now enrolling patients for the Phase 1 CERTAIN-T study of the lead candidate drug CER-1236.

Updated on Oct. 26, 2026 in Biotech

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Fred Hutch Cancer Center has activated a new clinical site in Seattle for the CERTAIN-T immunotherapy trial, testing CER-1236 for refractory AML patients. AI Illustration. Upload story photo >

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CERo Therapeutics has activated the Fred Hutch Cancer Center in Seattle as a new site for its Phase 1 CERTAIN-T clinical trial. The study evaluates the safety and clinical activity of its lead candidate, CER-1236, for patients with conditions including refractory AML.

Why it matters

The expansion of the CERTAIN-T trial into Seattle provides additional access to the experimental immunotherapy, which is currently undergoing safety and toxicity testing in humans. Monitoring trial sites is essential for tracking the clinical development of novel cell therapies targeting complex blood disorders.

In the first two patient cohorts, three subjects completed the 28-day dose-limiting toxicity assessment without adverse findings. One refractory AML patient successfully transitioned to an allogeneic stem cell transplant 71 days post-infusion.

The players

CERo Therapeutics

A South San Francisco-based biotech firm developing engineered T-cell therapies.

Fred Hutch Cancer Center

A Seattle-based research institution specializing in cancer care and stem cell transplantation.

Jacob Appelbaum

The principal investigator leading the CERTAIN-T clinical trial site at Fred Hutch.

The details

CER-1236 is a novel cell therapy being evaluated in an open-label Phase 1/1b study. The trial monitors pharmacokinetics—how the drug moves through the body—and pharmacodynamics to assess the biological impact of the treatment. Researchers are looking for dose-limiting toxicities, which are side effects serious enough to prevent further dose increases, in patients with refractory AML, MDS, and myelofibrosis.

Timeline

  1. October 26, 2026: Fred Hutch Cancer Center was activated as a clinical trial site.

  2. June 2026: CERo Therapeutics reported initial safety profile findings from early cohorts.

The Tech Race

The expansion of this Phase 1/1b study at Fred Hutch follows the initial safety data reported in June 2026. CERo Therapeutics is scaling site access to accelerate the evaluation of CER-1236 against standard cell therapy benchmarks.

Patients with refractory AML, MDS, or myelofibrosis in the Seattle area may now have access to the CERTAIN-T trial through Fred Hutch. Clinical availability remains limited to those meeting specific trial criteria as defined by the study protocol.

The takeaway

The successful 28-day toxicity assessment of the first two cohorts provides a baseline for the therapy's safety profile as the trial expands. Observers should track future safety and efficacy updates from the company to determine if the drug moves into larger Phase 2 testing.

Further reading

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