drugset / Trial / NCT06529731
Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
Phase 2
Recruiting
45 enrolled
Sawa Ito, MD
Amgen · collabEvans MDS Discovery Research Grant · collabFDA Office of Orphan Products Development · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and further contribute to this effort through the collection of leukemia cells pre- and post- in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Timeline
- Start
- 2024-09-23
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon gamma-1b | Protein / enzyme biologic | 50 ug/m2 | — |
| Subject | Interferon gamma-1b | Protein / enzyme biologic | 100 ug | — |