RECRUITING

A Safety and Tolerability Study of Jaktinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

Official Title

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

Quick Facts

Study Start:2024-07-01

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05279001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Jason Wu, M.D

CONTACT

+86-21-58942758

wujs@zelgen.com

Study Locations (Sites)

Site 01

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

Myelofibrosis