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

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

Plain Language Summary

Simplified for easier understanding

This trial tests CER-1236, a new type of immune cell therapy for acute myeloid leukemia (AML) — a fast-moving blood cancer. CER-1236 uses engineered immune cells designed to recognize and attack leukemia cells. **You may be eligible if...** - You have been diagnosed with AML or a pre-leukemia condition called MDS/AML (with 10–19% leukemia cells in the bone marrow) - Your blood lymphocyte count is sufficient for collecting immune cells - You have a good performance status (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously received a permanently gene-modified cell product (such as a prior CAR-T therapy) - There is no detectable leukemia in your bone marrow before any bridging therapy - You have an active autoimmune disease or have been treated for one within the last 2 years (exceptions apply for well-controlled thyroid disease or type 1 diabetes) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Sacramento, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Sarah Cannon Research Insitute

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06834282


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