Evaluating the safety of Jaktinib for treating Myelofibrosis
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
PHASE1 · Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT05279001
This study is testing if a new drug called Jaktinib is safe for people with Myelofibrosis who haven't had success with other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd (industry) |
| Drugs / interventions | jaktinib, chemotherapy, radiation |
| Locations | 1 site (Canton, Ohio) |
| Trial ID | NCT05279001 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is an open-label, single-arm, dose escalation study aimed at assessing the safety and tolerability of Jaktinib in patients diagnosed with Myelofibrosis who have relapsed or are refractory to existing JAK inhibitors. Participants will receive Jaktinib Hydrochloride tablets, and the study will monitor their responses to the treatment. The trial focuses on individuals with primary Myelofibrosis or those who have developed the condition after polycythemia vera or essential thrombocythemia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Myelofibrosis who have previously failed treatment with a marketed JAK inhibitor.
Not a fit: Patients currently undergoing chemotherapy, immunotherapy, or those with recent major surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with Myelofibrosis who have not responded to current therapies.
How similar studies have performed: While there have been studies on JAK inhibitors, this specific approach with Jaktinib is novel and has not been extensively tested in prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Canton, Ohio
- Site 01 — Canton, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Jason Wu, M.D
- Email: wujs@zelgen.com
- Phone: +86-21-58942758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myelofibrosis