CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCERo Therapeutics Holdings, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CER-1236
- Cyclophosphamide
- Fludarabine
- Mesna
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov