RecruitingRecruiting
CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
NCT06834282 · CERo Therapeutics Holdings, Inc.
In plain English
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Official title
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)
About this study
CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.
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.
The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).
Part 1 (Escalation Phase): The primary objectives of Part 1 are to define the safety of different doses of CER-1236 and to define the recommended dose for Part 2 (RP2D) of CER-1236.
Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efficacy of CER-1236 in patients with acute myeloid leukemia.
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.
Study design
Enrollment target: 18 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-07
Estimated completion: 2029-12-31
Last updated: 2026-03-27
Interventions
Drug: CER-1236Drug: CyclophosphamideDrug: FludarabineDrug: Mesna
Primary outcomes
- • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) (2 year)
- • Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1) (28 days)
- • Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2) (2 years)
Sponsor
CERo Therapeutics Holdings, Inc. · industry
All locations (4)
University of California, Davis Comprehensive Cancer CenterNot Yet Recruiting
Sacramento, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Sarah Cannon Research InsituteRecruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States