DR-18 for the Treatment of Relapsed or Persistent Acute Myeloid Leukemia or Myelodysplasti
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 (persiste
| Condition(s) | Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * ≥ 18 years of age (no upper age limit) * Documented persistent or recurrent AML or MDS after HCT (including measurable residual disease \[MRD\] or overt leukemia). Note: MRD (\< 5% malignant blasts) must be detected with flow cytometry testing at University of Washington Medical Center (UWMC)/Fred Hutchinson Cancer Center (Fred Hutch) clinical laboratory * No Food and Drug Administration (FDA)-approved targeted therapy for the subject's AML or MDS is available, or if such therapy is available, that class of drugs previously failed for the subject or the subject was intolerant of the therapy * No history of grade 3 or 4 acute GvHD after the most recent HCT * No history of moderate or severe chronic GvHD after the most recent HCT * No active acute or chronic GvHD or oth |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fred Hutchinson Cancer Center |
| Locations | Seattle, Washington, United States |
| Start date | 2024-09-23 |
| NCT ID | NCT06492707 |
| Official listing | https://clinicaltrials.gov/study/NCT06492707 |