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CER-1236 for AML, MDS, and Myelofibrosis

This study is testing a new cell therapy called CER-1236 for people with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or myelofibrosis (MF). CER-1236 is a type of T-cell therapy designed to target cancer cells. Participants will also receive standard chemotherapy drugs like Cyclophosphamide and Fludarabine, along with Mesna to protect against chemotherapy side effects. The main goals are to see how safe CER-1236 is and if it helps treat the cancer. Researchers will look for side effects and how well the treatment shrinks tumors or leads to a complete response. This study is for adults aged 18 to 85 who have certain types of AML or MDS, and a good general health status. The study is currently evaluating its status.

Study design
This is a first-in-human, multi-center, open-label study with a planned enrollment of 18 participants. It has two parts: a dose-finding phase and an expansion phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to monitor for side effects and treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06834282

CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

Recruiting
PHASE1Ages 18–85InterventionalTreatment
CERo Therapeutics Holdings, Inc.
~18 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CER-1236CyclophosphamideFludarabineMesna

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)
Measured over 2 year
+2 more outcomes measured

Conditions

AML
Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeMyelofibrosisTP53 Gene

Where it's being run

4 sites across 4 states
California1
Colorado1
Tennessee1
Texas1

Who to contact

Brian Jonas, MD
[email protected]
916-382-6970
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)2 year

    Escalation Period

  • Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)28 days

    Escalation Period

  • Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2)2 years

    Expansion Period