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NCT06834282 | RECRUITING | AML

CER-1236 in Patients With Acute Myeloid Leukemia (AML)
Sponsor:

CERo Therapeutics Holdings, Inc.

Brief 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.

Condition or disease

AML

Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia

Intervention/treatment

CER-1236

Cyclophosphamide

Fludarabine

Mesna

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 18 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1)
Actual Study Start Date : 2025-04-07
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
CER-1236 in Patients With Acute Myeloid Leukemia (AML)

Location Details

NCT06834282

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030