Actively Recruiting
CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Led by CERo Therapeutics Holdings, Inc. · Updated on 2026-03-27
18
Participants Needed
4
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 WHO 2022 classification
- Absolute lymphocyte count greater than 0.3 x 10^9/L prior to apheresis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Prior therapy with a permanently integrated, genetically modified cell product
- No measurable leukemia on screening bone marrow evaluation before any bridging therapy
- Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years (except well-controlled autoimmune thyroiditis or type 1 diabetes)
- Known severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents
- Any medical, psychological, or social condition that might interfere with study participation or patient safety
- Primary immunodeficiency disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Not Yet Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Sarah Cannon Research Insitute
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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