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)
CERo Therapeutics Holdings, Inc.
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.
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 recomm…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
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 disea…
Interventions
- DrugCER-1236
an autologous chimeric engulfment receptor T-cell
- DrugCyclophosphamide
Lymphodepleting chemotherapy
- DrugFludarabine
Lymphodepleting chemotherapy
- DrugMesna
Chemoprotectant
Locations (4)
- University of California, Davis Comprehensive Cancer CenterSacramento, California
- Colorado Blood Cancer InstituteDenver, Colorado
- Sarah Cannon Research InsituteNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas