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RecruitingPhase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CER-1236 in people for the first time to check its safety and early signs that it works. It is for people with acute myeloid leukemia (AML) that came back, did not respond to treatment, or still has small amounts of cancer after treatment, or disease with a change in the TP53 gene.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of AML, either new or linked to a past illness or treatment, or MDS/AML with 10% to 19% blasts (immature blood cells). MDS is a disorder in which bone marrow makes abnormal blood cells.
  • Have a lymphocyte count above 0.3 × 10⁹/L before blood cells are collected. Lymphocytes are a type of white blood cell.
  • Be fully active or able to walk and do light work, even if hard physical activity is limited.

Who can't join

  • Have had treatment with cells whose genes were permanently changed.
  • Have no measurable leukemia in the screening bone marrow test before any treatment given while waiting for study treatment.
  • Have an active autoimmune disease (when the body attacks itself), or one that needed treatment in the past 2 years. Well-controlled autoimmune thyroid disease or type 1 diabetes treated with replacement hormones is allowed.
  • Have a known allergy or severe reaction to fludarabine, cyclophosphamide, or ingredients or mixing liquids in the study drug.
  • Have another health, mental health, or social issue that the doctor thinks could make participation unsafe or make it hard to follow study rules.
  • Have a primary immune deficiency, a disorder that weakens the body's defenses against infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (5)

CA

CO

TN

TX

WA