AMLPhase 1CertainT-1NCT06834282
CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
A Phase 1 study testing CER-1236, Cyclophosphamide and Fludarabine in people with AML and Acute Myeloid Leukemia, run by CERo Therapeutics Holdings, Inc. at 5 sites in United States.
Trial summary
This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- What is being tested?
- CER-1236, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Apr 2025to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Maris Michael, MD, PSLMDLCBCINewClinicPatient@HCAHealthcare.com
Michael Maris, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Abhishek Maiti, MD, 713-745-3228, amaiti@mdanderson.org
Abhishek Maiti, MD
- Recruiting
Sarah Cannon Research Insitute
Nashville, Tennessee, 37203
AskSarah Help Line Have Cancer Questions? askSARAH | Sarah Cannon, 844-482-4812
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
Brian Jonas, MD, 916-382-6970, bajonas@health.ucdavis.edu
Alpha Stem Cell Clinic, 916-734-0753, OCRReferral@health.ucdavis.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Fred Hutch Immunotherapy Intake, 206-606-4668, Immunotherapy@fredhutch.org
About this study
Official title: Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)
This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.
Read the detailed description
CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.
This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.
The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).
Part 1 (Escalation Phase): The primary objectives of Part 1 are to define the safety of different doses of CER-1236 and to define the recommended dose for Part 2 (RP2D) of CER-1236.
Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efficacy of CER-1236 in patients with acute myeloid leukemia.
- Being tested
- CER-1236, Cyclophosphamide, Fludarabine, Mesna
- Keywords
- Relapsed Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CER-1236Drug
an autologous chimeric engulfment receptor T-cell
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
MesnaDrug
Chemoprotectant
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Agent CER-1236 | Experimental | AML patient treated with a single dose of CER-1236 monotherapy Receives: Drug: CER-1236; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
| Part 2: Single Agent CER-1236 | Experimental | AML patient treated with a single dose of CER-1236 monotherapy Receives: Drug: CER-1236; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)
Escalation Period
Measured: 2 year
Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)
Escalation Period
Measured: 28 days
Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2)
Expansion Period
Measured: 2 years
Secondary outcomes (4)
Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)
Escalation Period
Measured: 2 years
PK (Cmax) of CER-1236 - (Part 1)
Escalation Period
Measured: 2 years
PK (AUC) of CER-1236 - (Part 1)
Escalation Period
Measured: 2 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)
Expansion Period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start7 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multiple ascending dose and dose expansion study of CER-1236 administered as a single agent.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CERo Therapeutics Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834282
- Sponsor's protocol ID
- CER-1-1
- Acronym
- CertainT-1
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)
- ClinicalTrials.gov ID
- NCT06834282
- Acronym / sponsor ID
- CertainT-1 / CER-1-1
- Keywords
- Relapsed Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- CERo Therapeutics Holdings, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.
Detailed description
CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.
This is a first in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.
The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).
Part 1 (Escalation Phase): The primary objectives of Part 1 are to define the safety of different doses of CER-1236 and to define the recommended dose for Part 2 (RP2D) of CER-1236.
Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efficacy of CER-1236 in patients with acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple ascending dose and dose expansion study of CER-1236 administered as a single agent.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Agent CER-1236 | Experimental | Drug: CER-1236, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaAML patient treated with a single dose of CER-1236 monotherapy |
| Part 2: Single Agent CER-1236 | Experimental | Drug: CER-1236, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: MesnaAML patient treated with a single dose of CER-1236 monotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CER-1236an autologous chimeric engulfment receptor T-cell | Drug | Part 1: Single Agent CER-1236, Part 2: Single Agent CER-1236 |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Part 1: Single Agent CER-1236, Part 2: Single Agent CER-1236 |
| FludarabineLymphodepleting chemotherapy | Drug | Part 1: Single Agent CER-1236, Part 2: Single Agent CER-1236 |
| MesnaChemoprotectant | Drug | Part 1: Single Agent CER-1236, Part 2: Single Agent CER-1236 |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)
Time frame: 2 year
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)
Time frame: 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)
Time frame: 2 years
Expansion Period
4 secondary outcomes
Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)
Time frame: 2 years
PK (Cmax) of CER-1236 - (Part 1)
Time frame: 2 years
PK (AUC) of CER-1236 - (Part 1)
Time frame: 2 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of California, Davis Comprehensive Cancer Center
Sacramento, United States
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CER-1236, Cyclophosphamide and Fludarabine in people with AML and Acute Myeloid Leukemia, run by CERo Therapeutics Holdings, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) (time frame: 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.