New treatment for patients with relapsed acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States 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
• Fred Hutchinson Cancer Center
  Seattle, Washington, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CRD3874-SI in People with Leukemia

  A small early-stage study tests CRD3874-SI to see if it is safe for adults with relapsed or refractory acute myeloid leukemia.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07661095

• Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS

  This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT07493538

• Decitabine plus FLAG‑Ida chemotherapy and total‑body irradiation before donor stem cell transplant for adults with high‑risk myeloid cancers

  This test tries whether adding decitabine to FLAG‑Ida chemotherapy and total‑body irradiation before a donor stem cell transplant helps adults with high‑risk or relapsed myeloid blood cancers live longer and stay in remission.

  Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06928662

• Evaluating a new chemotherapy regimen for relapsed or refractory AML

  This study is testing a new combination of chemotherapy drugs to see if it can help people with acute myeloid leukemia that hasn't responded to other treatments.

  Recruiting Phase 2 Beijing 302 Hospital · Beijing · NCT06741722

• Testing a new anti-cancer drug for patients with acute myeloid leukemia and myelodysplastic syndromes

  This study is testing a new anti-cancer drug called cirtuvivint, alone and with another drug, to see if it helps people with acute myeloid leukemia and myelodysplastic syndromes feel better and live longer.

  Recruiting at 20 sites Phase 1 National Cancer Institute (NCI) · New Haven, Connecticut and 22 other locations · NCT06484062

• CAR-T cell therapy targeting CD33 and CD123 for treating acute myeloid leukemia

  This study is testing a new CAR-T cell therapy that targets specific markers in the blood to see if it can help people with acute myeloid leukemia who haven't responded to other treatments.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT06420063

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.