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
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