Jaktinib for Myelofibrosis

Overseen By Jason Wu, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Must not be taking: Chemotherapy, Corticosteroids, Immunosuppressives, others

Disqualifiers: Pregnancy, Breastfeeding, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Jaktinib, to determine its effectiveness in treating myelofibrosis, a rare bone marrow disorder that disrupts blood cell production. Researchers aim to assess whether Jaktinib is safe and effective for individuals whose previous treatments with other JAK inhibitors have failed. Ideal participants are those diagnosed with myelofibrosis who have not found success with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatments at least 14 days before starting the study drug.

Is there any evidence suggesting that Jaktinib is likely to be safe for humans?

Research shows that Jaktinib is generally well-tolerated by patients with myelofibrosis. Studies have found that it can reduce spleen size and improve symptoms like anemia, a low red blood cell count. These benefits come with good tolerability, meaning most patients handle the treatment well without serious side effects. While some patients may experience side effects, these are usually manageable. Potential participants should know that this trial is in its early stages, so researchers are closely monitoring safety as they gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Jaktinib is unique because it targets specific pathways involved in myelofibrosis that are not addressed by current standard treatments like ruxolitinib. Researchers are excited about Jaktinib because it offers a new mechanism of action by inhibiting JAK2/FLT3, which could provide more effective control of disease symptoms and progression. This approach may offer hope for patients who have not responded well to existing therapies, potentially leading to improved outcomes.

What evidence suggests that Jaktinib might be an effective treatment for Myelofibrosis?

Research has shown that Jaktinib, the investigational treatment in this trial, could be promising for myelofibrosis, a rare bone marrow disorder. Studies have found that Jaktinib can reduce an enlarged spleen and improve symptoms in patients who couldn't tolerate other treatments like ruxolitinib. Patients taking Jaktinib have reported ongoing improvements in their condition. Additionally, Jaktinib may help those who have become resistant to or relapsed after other treatments. These findings suggest that Jaktinib may offer new hope for effectively managing myelofibrosis symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with myelofibrosis who haven't responded well to standard treatments. They should be relatively stable (ECOG PS 0, 1, or 2) and expected to live more than 24 weeks. Pregnant or breastfeeding women can't join, nor those planning pregnancy without effective contraception.

Inclusion Criteria

Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).

Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.

ECOG PS 0, 1, or 2.

Exclusion Criteria

Major surgery or radiation therapy within 28 days prior to initiation of study drug.

Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.

Females who are pregnant, currently breastfeeding, planning to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of Jaktinib to evaluate safety and tolerability

4 weeks

Treatment

Participants receive Jaktinib for safety and efficacy evaluation

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to approximately 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Jaktinib

Trial Overview The study is testing Jaktinib Hydrochloride Tablets as a new treatment option for Myelofibrosis. It's aimed at patients who have not had success with existing FDA-approved JAK inhibitors.

How Is the Trial Designed?

Group I: Jaktinib Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead Sponsor

Trials

70

Recruited

8,600+

Dr. Zelin Sheng

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Executive Officer since 2009

PhD

Dr. Qingping Gao

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Jaktinib, a selective Janus kinase 1/2 inhibitor, was well tolerated in a phase I study involving 126 healthy Chinese subjects, with no serious adverse events reported, indicating a favorable safety profile.

The pharmacokinetics of jaktinib showed linear characteristics across doses from 25 to 400 mg, with a median time to peak concentration of 1.25-3.5 hours and a half-life of approximately 3-9 hours, supporting its further investigation in patients with myelofibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance, Pharmacokinetics of Jaktinib, a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers. Liu, J., Lv, B., Yin, H., et al.[2021]

In a phase 2 trial involving 51 patients with myelofibrosis who were intolerant to ruxolitinib, 43.2% of those treated with the novel JAK inhibitor jaktinib showed a significant reduction in spleen volume after 24 weeks.

Jaktinib also improved symptoms related to myelofibrosis, with 61.8% of patients experiencing a notable decrease in total symptom scores, although it was associated with some serious adverse events, including anemia and thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. Zhang, Y., Zhou, H., Duan, M., et al.[2023]

Ruxolitinib is a dual inhibitor of JAK1 and JAK2, which are crucial in the development of myelofibrosis (MF), and it has been FDA-approved since November 2011 for treating intermediate or high-risk MF.

The review discusses Ruxolitinib's current role in managing MF and explores its potential future applications in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Janus activated kinase inhibition in myelofibrosis. Malhotra, H.[2021]

Ruxolitinib, the only approved JAK inhibitor for myelofibrosis (MF), has been shown to be effective in managing the disease, significantly changing treatment approaches since its introduction.

While JAK inhibitors can cause side effects like anemia, thrombocytopenia, and increased infection risk, these effects are generally predictable and manageable with careful monitoring and dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing side effects of JAK inhibitors for myelofibrosis in clinical practice. Saeed, I., McLornan, D., Harrison, CN.[2021]

In a phase 2 trial involving 118 patients with myelofibrosis, jaktinib demonstrated significant efficacy, with 54.8% of patients on the 100 mg BID dosage achieving a ≥35% reduction in spleen volume at week 24, compared to 31.3% in the 200 mg QD group.

Jaktinib also improved hemoglobin levels in 35.6% of patients with low baseline hemoglobin and resulted in a ≥50% improvement in total symptom scores for 69.6% of patients in the BID group, indicating its potential as a well-tolerated treatment option for myelofibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of jaktinib in the treatment of Janus kinase inhibitor-naïve patients with myelofibrosis: Results of a phase II trial. Zhang, Y., Zhou, H., Jiang, Z., et al.[2023]

Ruxolitinib is commonly used for managing myelofibrosis symptoms, but many patients experience treatment failure after 2-3 years, highlighting the need for alternative therapies like fedratinib.

Fedratinib has shown efficacy in reducing spleen volume and symptoms in patients with myelofibrosis, and ongoing trials are focused on understanding its long-term effects and managing potential gastrointestinal toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fedratinib: a pharmacotherapeutic option for JAK-inhibitor naïve and exposed patients with myelofibrosis. England, JT., Gupta, V.[2022]

In a study of 219 patients with myelofibrosis, ruxolitinib demonstrated a significant efficacy advantage over the best available therapy, with 28% of patients achieving at least a 35% reduction in spleen volume at 48 weeks, compared to 0% in the control group.

Ruxolitinib not only reduced spleen size but also improved overall quality of life and disease symptoms, with manageable side effects, primarily hematologic issues like thrombocytopenia and anemia, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. Harrison, C., Kiladjian, JJ., Al-Ali, HK., et al.[2022]

Ruxolitinib, the first approved treatment for myelofibrosis (MF), has shown significant improvements in spleen size and related symptoms in patients, based on results from Phase I/II and Phase III clinical trials involving direct comparisons to placebo and best available therapy.

While ruxolitinib is effective, it can cause side effects like cytopenias, which can be managed with dose adjustments, and there have been rare cases of infections related to immunosuppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ruxolitinib for myelofibrosis. Santos, FP., Verstovsek, S.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655548/

Evaluation of gecacitinib vs hydroxyurea in patients with ... To compare the efficacy and safety of gecacitinib (also known as jaktinib) with hydroxyurea (HU) in treating myelofibrosis (MF) patients.

2. onclive.com onclive.com/view/jaktinib-reduces-splenomegaly-improves-symptom-burden-in-ruxolitinib-intolerant-myelofibrosis

Jaktinib Reduces Splenomegaly, Improves Symptom ... At the data cutoff of April 22, 2022, treatment was ongoing in 68.9% (n = 31) of patients receiving jaktinib at 100 mg twice daily. Although 45 ...

3. mpn-hub.com mpn-hub.com/medical-information/jaktinib-for-patients-with-mf-final-results-from-the-phase-iii-zgjak016-trial

Jaktinib for patients with MF: Final results from the phase III ... Here, we summarize a long-term follow-up of ZGJAK002, a phase II trial assessing efficacy and safety of jaktinib, a deuterated form of momeloti.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03886415

Jaktinib Hydrochloride Tablets in Intermediate-risk and ... ... Efficacy of Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis. ... Primary Myelofibrosis. Plan for Individual Participant Data (IPD).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37466271/

Safety and efficacy of jaktinib (a novel JAK inhibitor) in ... These results indicate that jaktinib can be a promising treatment option for patients with MF who have either become refractory to or relapsed after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05279001

NCT05279001 | A Safety and Tolerability Study of Jaktinib This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis. ... Safety of jaktinib hydrochloride tablets, Number of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092883/

Safety and efficacy of jaktinib in the treatment of Janus kinase ... These results indicate that jaktinib can shrink the spleen, improve anemia, and other clinical symptoms with good tolerability. 1. INTRODUCTION. Myelofibrosis ( ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/336315

A Safety and Tolerability Study of Jaktinib This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis. ... Safety of jaktinib hydrochloride tablets. Measure ...