Recruiting
Phase 1

Jaktinib

Sponsor:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Code:

NCT05279001

Conditions

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Jaktinib Hydrochloride Tablet

Study Details

Brief summary:

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

Conditions

Myelofibrosis

Study ID

NCT05279001

Start date

Jul 1, 2024

Status verified date

Mar, 2024

Completion date

Nov 30, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Jaktinib

Interventions

Jaktinib Hydrochloride Tablet

Orally administered, twice a day

Primary outcome measure

  • Safety of jaktinib hydrochloride tablets [ Time Frame: At least 24 weeks, up to approximately 1 year for follow-up ]
  • Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Jason Wu, M.D

+86-21-58942758wujs@zelgen.com

Locations

Site 01

Recruiting

Canton, Ohio, United States, 44718

Contacts

Jason Wu

wujs@zelgen.com

More Information

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Last update posted

Mar 21, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Suzhou Zelgen Biopharmaceuticals Co.,Ltd on 2024-03-21.