RecruitingPhase 1NCT06834282

CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

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)

Sponsor

CERo Therapeutics Holdings, Inc.

Enrollment

18 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia AML Refractory Acute Myeloid Leukemia

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria6

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.