DR-18 to Prevent or Treat Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapse After Hematopoietic Cell Transplantation, the DR. DREAM Trial

This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and/or effective in treating patient with relapsed or persistent AML or MDS after HCT.

NCT Number	NCT06492707
Lead Sponsor	Fred Hutchinson Cancer Center Collaborators: Simcha Therapeutics
Conditions	Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome
Enrollment	40 participants
Start Date	2024-09-23
Primary Completion	2027-10-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-10