A Safety and Tolerability Study of Jaktinib

Zelgen Biopharmaceuticals

Status and phase

Enrolling

Phase 1

Conditions

Myelofibrosis

Treatments

Drug: Jaktinib Hydrochloride Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05279001

ZGJAKUS001

Details and patient eligibility

About

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

Full description

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

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.