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

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.

Eligibility

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.

Conditions4

Locations3 sites

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