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New drug combo for rare bone marrow cancer shows early promise, but trial halted

NCT ID NCT06245941

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested two experimental drugs, TQ05105 and TQB3909, taken together as tablets for people with moderate- to high-risk myelofibrosis, a rare bone marrow disorder. The goal was to see if the combination could shrink an enlarged spleen and improve symptoms. The trial enrolled 21 adults and was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TQ05105 and TQB3909 tablets
What this could lead to
If successful, this combination could offer a new treatment option for people with moderate- to high-risk myelofibrosis, potentially reducing spleen size and improving symptoms.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early-phase study, so even if data are positive, much more testing is needed. The drugs may cause side effects like low blood counts or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

21 people

The number who actually took part.

Started

May 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) * 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. Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hennan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300122, China

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230012, China

  • Xijing Hospital of the Fourth Military Medical University

    Xi'an, Shaanxi, 710032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.