CER-1236 in Patients With Acute Myeloid Leukemia (AML)

Launched by CERO THERAPEUTICS HOLDINGS, INC. · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial, titled CER-1236, is looking at a new treatment for patients with acute myeloid leukemia (AML), specifically those whose disease has come back after previous treatments or has not responded to standard therapies. The study is in its early phases and aims to determine if CER-1236 is safe and if it can help reduce the cancer in patients who have measurable remnants of leukemia or specific genetic mutations.

To participate in this trial, patients must be between the ages of 65 and 74, and have a confirmed diagnosis of AML or related conditions. They should also have a certain level of immune cells in their blood and a specific performance status that indicates they can carry out daily activities. However, there are some criteria that would exclude patients, such as having previously received certain types of genetically modified treatments or having serious allergic reactions to specific medications. If eligible, participants can expect regular monitoring and care while receiving the study treatment, contributing to our understanding of how this new therapy works for AML.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.