NCT06414681

Combination of Tagraxofusp with Pacritinib in Patients with Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy with the Approved JAK Inhibitors or in Which Therapy with the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined

An Open Label Pilot Trial of the Combination of Tagraxofusp with Pacritinib in Patients with Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy with the Approved JAK Inhibitors or in Which Therapy with the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this open-label, single-center, pilot trial is to test the combination of Tagraxofusp (TAG) with Pacritinib (PAC) in patients with intermediate-II or higher myelofibrosis (MF), who have had prior therapy with the approved JAK1/2 inhibitor or in which therapy with the approved JAK1/2 inhibitors is not appropriate, contraindicated or declined by the subjects. The Primary Objective is to: 1\. Characterized efficacy of the combination of Tagraxofusp and Pacritinib. The Secondary Objective is to: 1\. characterize the safety profile of the combination Tagraxofusp and Pacritinib. 2, Characterize the feasibility of the combination Tagraxofusp and Pacritinib. 3. Characterize hematologic improvement with the combination Tagraxofusp and Pacritinib. 4\. Evaluate and compare the effect of Tagraxofusp and Pacritinib on participant reports of MF symptoms. Exploratory: Pharmacokinetic (PK) testing of Tagraxofusp and Pacritinib to assess clinical predictors of response. Next Generation Sequencing (NGS) Testing to define the number and the allele burden of pathological mutations, as well as the changes over the course of therapy, both in regard to progression and response. Blood will be collected and stored at KU BRCF for future study related PK analysis

Detailed description

A combination of these agent provides rational scientific merit and compatible mechanisms of action by targeting myelofibrosis stem cells and BM environment, in combination with effective JAK2 and IRAK1 inhibition resulting in improvement in MPN related symptoms and splenomegaly without overlapping toxicities. Both agents have been studied in mildly depleted bone marrow phenotypes showing safety and hematological improvements

Conditions

• Myelofibrosis，MF

Interventions

Type	Name	Description
DRUG	Tagraxofusp	Tagraxofusp Patients will receive 12 micrograms/kg of Tagraxofusp (TAG) by IV infusion once daily for 3 consecutive days.
DRUG	Pacritinib	Pacritinib Pacritinib (PAC) will be given orally, 200 mg twice per day starting at C2D4 and administered continuously (Subsequent cycles start on Day 1 of the Cycle).

Timeline

• Start date: 2025-03-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-16
• Last updated: 2025-03-30

Regulatory

• FDA-regulated drug study