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MyelofibrosisPhase 1/2NCT06245941

A Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Myelofibrosis (MF)

A Phase 1/2 study testing TQ05105 tablets and TQB3909 tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 tablets combined with TQB3909 tablets in patients with moderate- and high-risk Myelofibrosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis
What is being tested?
TQ05105 tablets and TQB3909 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesChina
Study dates
13 May 2024to 30 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the study and signed informed consent with good compliance;
  • Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2; Life expectancy ≥ 24 weeks;
  • Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV-MF), or post essential thrombocythemia myelofibrosis (post-ET-MF);
  • Those with moderate or high risk myelofibrosis evaluated according to Dynamic International Prognostic Scoring System (DIPSS) prognostic grading criteria, or those with high risk myelofibrosis according to National Comprehensive Cancer Network (NCCN) guidelines prognostic grading criteria;
  • Patients with poor efficacy of JAK inhibitors (for monotherapy of TQB3909, phase Ib and phase II cohort 2);
  • Patients who had not received JAK inhibitor treatment (for phase Ib and phase II cohort 2)
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  • Spleen enlargement;
  • Peripheral blood primary cells and bone marrow primary cells are ≤10%;
  • No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration
  • The Main organ function is normal;
  • Men and women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study.

Who cannot join

  • Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
  • Patients who have previously received BCL-2 inhibitor combined with JAK inhibitor therapy;
  • Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
  • Other malignancies within 3 years prior to first administration or currently present.
  • Patients with multiple factors affecting oral or absorption of drugs;
  • Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
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  • Presence of congenital bleeding disorder and congenital coagulopathy;
  • Patients who had arterial/venous thrombosis events within 6 months before the first administration.
  • Have a history of mental drug abuse, or have a mental disorder.
  • Active or uncontrolled severe infection;
  • Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection , or active Corona Virus Disease 2019 (COVID-19) infection;
  • Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first administration;
  • Unsatisfactory blood pressure control despite standard therapy;
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis;
  • Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
  • Patients with a history of immunodeficiency disease or organ transplantation;
  • Patients with epilepsy requiring treatment;
  • Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
  • There is a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period.
  • People with known hypersensitivity to the study drug and excipients;
  • Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
  • Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration
  • Any MF treatment drugs, any immunomodulators, or any immunosuppressants were used within 2 weeks prior to the first dose
  • According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230012

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300122

  • Xijing Hospital of the Fourth Military Medical University

    Xi'an, Shaanxi, 710032

  • Hennan Cancer Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3909 Tablets in the Treatment of Moderate- and High-risk Myelofibrosis

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 tablets combined with TQB3909 tablets in patients with moderate- and high-risk Myelofibrosis.

Conditions
Myelofibrosis
Being tested
TQ05105 tablets, TQB3909 tablets
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ05105 tabletsDrug

    TQ05105 is a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) Inhibitor

  • TQB3909 tabletsDrug

    TQB3909 is an inhibitor targeting B-cell lymphoma-2 (BCL-2) protein.

Study groups in NCT06245941
Study groupRoleWhat they receive
TQB3909 TabletsExperimentalTQB3909 Tablets, orally administered. 28 days as a treatment cycle.
Receives: Drug: TQB3909 tablets
TQ05105 Tablets combined with TQB3909 TabletsExperimentalTQ05105 Tablets combined with TQB3909 Tablets, orally administered. 28 days as a treatment cycle.
Receives: Drug: TQ05105 tablets; Drug: TQB3909 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal tolerance dose (MTD)

    If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered as MTD.

    Measured: Up to 2 years.

  2. Recommended phase II dose (RP2D)

    The RP2D is defined as the lower dose level to MTD based on the safety profile

    Measured: Up to 2 years

  3. 35% reduction in spleen volume (SVR35) at week 24

    The proportion of subjects with a ≥35% reduction in spleen volume from baseline at the end of treatment at week 24

    Measured: Up to 24 weeks

Secondary outcomes (12)

  1. Optimum effective rate

    The proportion of subjects with at least once spleen volume reduction ≥ 35% from baseline

    Measured: Up to 120 weeks

  2. Onset time of splenic response

    The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from baseline

    Measured: Up to 120 weeks

  3. Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)

    The time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction is < 35% from baseline.

    Measured: Up to 120 weeks

  4. Percentage change in spleen volume from baseline

    Percentage change in spleen volume of subjects from baseline after treatment.

    Measured: Up to 60 weeks

  5. SVR35 at week 60

    The proportion of subjects with a ≥35% reduction in spleen volume compared to baseline after treatment at week 60.

    Measured: Up to 60 weeks

  6. Myeloproliferative neoplasm - Symptom Assessment Form - Total Symptom Score (MPN-SAF-TSS)

    The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% from baseline. MPN-SAF-TSS is a tool for evaluating the disease burden of patients with myeloproliferative neoplasms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels, the sum of 10 symptom scores is MPN-SAF-TSS score. The higher the score, the more severe the symptoms are.

    Measured: Up to 60 weeks

  7. MPN-SAF-TSS decrease

    The time and duration when the MPN-SAF-TSS decreased by ≥50% compared to baseline for the first time.

    Measured: Up to 60 weeks

  8. Progression-free survival (PFS)

    The time interval from the first dose to the date of the occurrence of any of the following events, whichever occurs first:(1) Spleen volume increased by ≥25% compared with the screening period ; (2) Death caused by any cause.

    Measured: Up to 120 weeks

  9. Leukemia free survival (LFS)

    The time interval from the date of the first dose to the date of any of the following events, whichever occurs first: (1) the date of the first bone marrow smear showing the original cell ≥20% ;(2) The first peripheral blood smear showed that the original cells ≥ 20% and the absolute value of the original cells ≥1×10^9/L and lasted for at least 2 weeks; (3) Death caused by any reason.

    Measured: Up to 120 weeks

  10. Overall Survival (OS)

    The time from the first time the subject received treatment to death due to any cause

    Measured: Up to 120 weeks

  11. Incidence of adverse events (AEs)

    Incidence rate of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Measured: Baseline up to 120 weeks

  12. Severity of adverse events (AEs)

    Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

    Measured: Baseline up to 120 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start13 May 2024
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Why it stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245941
Sponsor's protocol ID
TQ05105-TQB3909-Ib/II-01
Status last verified
Jul 2025
First submitted
30 Jan 2024
Last updated
5 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQ05105 tablets and TQB3909 tablets in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal tolerance dose (MTD) (time frame: Up to 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06245941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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