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Engineered T-Cells take on tough blood cancers in first human trial

NCT ID NCT06834282

Disease control Sponsor: CERo Therapeutics Holdings, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This early-phase study tests a new treatment called CER-1236 for people with certain blood cancers (acute myeloid leukemia, myelodysplastic syndrome, or myelofibrosis) that have not responded to standard therapy. The treatment uses a patient's own immune cells, which are modified in a lab to better recognize and attack cancer cells. The main goals are to check safety and see if the therapy can shrink or eliminate the cancer.

Why investors are watching

Cero Therapeutics is testing its first drug in humans, CER-1236, a cell therapy for patients with certain blood cancers that have not responded to standard treatment. This early-stage trial is the first real-world check of the company's core technology, and for a micro-cap company with few other assets, the outcome will heavily shape its future.

If it works: If the trial shows the therapy is safe and shows signs of working, Cero could advance the drug to later-stage testing and attract partnership or funding interest. A positive result would validate the company's main scientific bet.

If it fails: Early-stage trials often fail to show enough benefit or reveal safety problems, and this one is very small, so results may be inconclusive. A failure or delay could leave Cero without a clear path forward, which is a real risk for a company of this size.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification. * Absolute lymphocyte count \>0.3 x 109/L prior to apheresis. * Eastern cooperative oncology group (ECOG) performance status 0 to 1. Exclusion Criteria: * Prior therapy with a permanently integrated, genetically modified cell product. * No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy. * Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible. * A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents. * Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician. * Primary immunodeficiency disorder.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia AML Refractory acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

    Contact Email: •••••@•••••

  • Fred Hutchinson Cancer Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98109, United States

  • Sarah Cannon Research Insitute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California, Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.