New treatment for patients with relapsed acute myeloid leukemia
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)
This study is testing a new treatment called CER-1236 to see if it can help people with relapsed acute myeloid leukemia feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | CERo Therapeutics Holdings, Inc. Industry-sponsored |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 4 sites (Sacramento, California and 3 other locations) |
| Trial ID | NCT06834282 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, multi-center, open-label phase 1/1b study evaluating the safety and preliminary efficacy of CER-1236, a novel chimeric engulfment receptor T-cell therapy, in patients with relapsed or refractory acute myeloid leukemia (AML) or TP53 mutated disease. The study consists of two parts: the first part focuses on determining the safety and recommended dose of CER-1236, while the second part assesses its efficacy in a larger cohort of patients. Participants will receive CER-1236 along with other treatments such as cyclophosphamide and fludarabine.
Who should consider this trial
Good fit: Ideal candidates include patients with relapsed or refractory acute myeloid leukemia who have measurable residual disease or TP53 mutations.
Not a fit: Patients with active autoimmune diseases or those who have previously received genetically modified cell therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of acute myeloid leukemia.
How similar studies have performed: While this approach is novel, similar therapies targeting specific receptors have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sacramento, California and 3 other locations
- University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (Not_yet_recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Sarah Cannon Research Insitute — Nashville, Tennessee, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.