Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
Summary
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML. The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in this patient population. Then, once RP2D is determined, to determine the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Timeline
- Start
- 2023-11-20
- Primary completion
- 2025-05-05
- Completion
- 2025-07-16
Outcome
Outcome not reported
Stopped (Enrollment): “Upon analysis of the first 7 participants accrued, it was determined that this combination treatment is not efficacious as treatment for patients with relapsed or refractory AML”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tagraxofusp | Protein / enzyme biologic | 7 ug/kg | — |
| Subject | Tagraxofusp | Protein / enzyme biologic | 9 ug/kg | — |
| Subject | Tagraxofusp | Protein / enzyme biologic | 12 ug/kg | — |
| Background | Gemtuzumab | Monoclonal antibody | 3 mg/m2 | Intravenous |