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Chimeric engulfment receptor (CER) T-cell therapy (CER-1236), to treat acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 - 85

Phase 1

3 Locations

NCT06834282

Clinical Trial Goal


To find out:
  • The highest dose of CER-1236 that's safe to give
  • If CER-1236 is safe and works well to treat AML or MDS that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 - 85 years old
  • Have AML or MDS that has relapsed or is refractory
  • Have not been treated with a genetically modified cell therapy. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


CER stands for chimeric engulfment receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
CER-1236 is a type of CER T-cell therapy that targets the TIM-4 ligand. 
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells. 

To make CER T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow synthetic receptors called CERs. CERs help T cells find the cancer cells. The CER T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
 
Before the CER-1236  infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
  • Cyclophosphamide – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
  • Fludarabine –  Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been

Then, CER-1236 is given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.

The clinical trial doctors will watch you closely over 2 years. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.

The Food and Drug Administration (FDA) has not yet approved CER-1236.  

Locations


Colorado Blood Cancer InstituteRECRUITING

Denver, Colorado
Yazan Migdady, MD, 720-754-4835, PSLMDLCBCINewClinicPatient@HCAHealthcare.com

Sarah Cannon Research InsituteRECRUITING

Nashville, Tennessee
AskSarah Help Line Have Cancer Questions? askSARAH | Sarah Cannon, 844-482-4812

The University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas
Abhishek Maiti, MD, 713-745-3228, amaiti@mdanderson.org

ClinicalTrials.gov record


NCT06834282. First posted on 2/19/25

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