NCT06492707

DR-18 for the Treatment of Relapsed or Persistent Acute Myeloid Leukemia or Myelodysplastic Syndrome After Hematopoietic Cell Transplantation, the DR. DREAM Trial

Decoy-Resistant Interleukin-18 (DR-18) for Relapse or Pre-emptive Treatment of Measurable Residual Disease After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (DR. DREAM)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OUTLINE: This is a dose-escalation study. INDUCTION: Patients receive DR-18 subcutaneously (SC) once weekly on approximately days 0, 7, 14, and 21. MAINTENANCE: Two weeks after induction treatment, patients without grade 3-4 acute GVHD, grade 2 acute GVHD requiring ongoing systemic immunosuppression, or moderate/severe chronic GVHD may receive DR-18 SC once weekly on approximately days 35, 42, 49 and 56. Additionally, patients undergo blood and bone marrow sample collection throughout the study. After completion of study treatment, patients are followed weekly for 4 weeks, monthly through 6 months and at 12 months.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Recurrent Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Decoy-resistant interleukin-18	Given SC
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration

Timeline

• Start date: 2024-09-23
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2024-07-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study