drugset / Trial / NCT06548230
A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.
Timeline
- Start
- 2025-03-05
- Primary completion
- 2027-12-01
- Completion
- 2029-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | — | Intravenous |
| Subject | NIDANILIMAB | Monoclonal antibody | — | Intravenous |
| Subject | Venetoclax | Small molecule | — | Oral |