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A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor


Description

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor

Trial Eligibility

Inclusion Criteria: * Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia). * Relapsed/refractory to a marketed (FDA approved) JAK inhibitor. * At least 18 years of age. * ECOG PS 0, 1, or 2. * Expected life expectancy is greater than 24 weeks. Exclusion Criteria: * Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. * Major surgery or radiation therapy within 28 days prior to initiation of study drug. * With suspected allergies to jaktinib or its excipient. * Another clinical trial of a new drug or medical instrument within 3 months before screening. * Females who are pregnant, currently breastfeeding, planning to become pregnant. * Unable to adopt effective contraceptive methods during the study.

Study Info

Organization

Suzhou Zelgen Biopharmaceuticals Co.,Ltd


Primary Outcome

Safety of jaktinib hydrochloride tablets


Outcome Timeframe At least 24 weeks, up to approximately 1 year for follow-up

NCTID NCT05279001

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-07-01

Completion Date 2025-05-31

Enrollment Target 26

Interventions

DRUG Jaktinib Hydrochloride Tablet

Locations Recruiting

Site 01

United States, Ohio, Canton


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