CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Start Date
4/7/2025
Completion Date
12/31/2029
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.
Detailed Description
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
Age Range: 18 years to 85 years
Interventions
CER-1236
Cyclophosphamide
Fludarabine
Mesna
Conditions
Locations
University of California, Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Colorado Blood Cancer Institute
Denver, Colorado 80218
United States
Sarah Cannon Research Insitute
Nashville, Tennessee 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States