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Recruiting Phase 1

CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

NCT06834282 · tracked via the Priya Life Science USA tracker
Sponsor
CERo Therapeutics Holdings, Inc
Phase
Phase 1
Started
2025-04-07
Last updated
2026-10-21

Condition(s) studied

AMLAcute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

CER-1236Cyclophosphamide →Fludarabine →Mesna →

CER-1236: an autologous chimeric engulfment receptor T-cell

Cyclophosphamide: Lymphodepleting chemotherapy

Fludarabine: Lymphodepleting chemotherapy

Mesna: Chemoprotectant

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
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 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.

Primary outcome measure(s)

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) — 2 year
    Escalation Period
  • Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1) — 28 days
    Escalation Period
  • 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
    Expansion Period

Trial sites (5)

FacilityCityRegionStatus
University of California, Davis Comprehensive Cancer Center Sacramento California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Sarah Cannon Research Insitute Nashville Tennessee Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06834282 on ClinicalTrials.gov ↗ ← All trials in the USA