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Myeloid MalignancyPhase 1/2NCT07011186

A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies

A Phase 1/2 study testing TQB3909 Tablets + Azacitidine in people with Myeloid Malignancy, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 21 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open, multi-center clinical study designed to evaluate the safety, tolerability and efficacy of TQB3909 tablets in combination with azacitidine in subjects with myeloid malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Malignancy
What is being tested?
TQB3909 Tablets + Azacitidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
21 sitesChina
Study dates
17 Apr 2024to Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Voluntary and signed informed consent, good compliance
  • Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months.
  • Diagnosis of one of the following diseases:
  • Acute Myeloid Leukemia (AML):
  • Myelodysplastic Syndromes (MDS)
  • Major organ functions are normal.
  • Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.

Who cannot join

  • Comorbidities and Medical History:
  • Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
  • Presence of multiple factors affecting oral drug intake and/or absorption;
  • Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
  • History of arterial/venous thrombotic events within 6 months prior to the first dose;
  • History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
Show all 15Show fewer
  • Presence of any severe and/or uncontrolled disease in the subject.
  • Tumor-related Symptoms and Treatment:
  • Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
  • Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
  • Subjects with extramedullary disease only in AML;
  • Presence of life-threatening severe leukemia-related complications;
  • Study Treatment-related:
  • Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
  • Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

JianXiang Wang, Master contact

13821389157

wangjx@ihcams.ac.cn

21 sites in 1 country

China21 sites, 21 recruiting

  • Beijing Chaoyang Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100020

    Wenming Chen, Doctor, 13910107759, 13910107759@163.com

    Not yet recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Hao Jiang, Master, 13601164350, Jiangha0090@sina.com

    Not yet recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

    Lihong Li, Master, 13501390152, llh1966@hotmail.com

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233000

    JunFeng Zhu, Master, 15215526662, Zhujunfeng517@163.com

    Not yet recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 67020

    Zhihua Zhang, Master, 15633142950, zzhangzhihua@163.com

    Not yet recruiting

  • People's hospital of deyang city

    Deyang, Sichuan, 618099

    Jie Zhou, Master, 13881055441, zhoujie_gcp@163.com

    Not yet recruiting

  • Harbin The First Hospital

    Harbin, Heilongjiang, 150010

    Tiejun Gong, Master, 13836027737, arc@sina.con

    Not yet recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

    ShanHao Tang, Doctor, 13777113112, txtx1978@163.com

    Not yet recruiting

  • ShangHai Tongren Hospital

    Shanghai, Shanghai Municipality, 200000

    LiGen Liu, Master, 18017337037, llg3532@shtrhospital.com

    Recruiting

  • Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

    Shanghai, Shanghai Municipality, 200437

    Wenwei Zhu, Doctor, 18930565525, wwz3006@163.com

    Lin Geng, Master, 021-5538591, Drgenglin@163.com

    Not yet recruiting

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai Municipality, 201200

    Guangru Xu, Master, 13916950375, xuggrr@sina.com

    Not yet recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Wei Yang, Doctor, 18940251012, yangw@sj-hospital.org

    Not yet recruiting

  • Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)

    Taian, Shandong, 271099

    Guanchen Bai, Bachelor, 18653819776, bgcbgc1@163.com

    Not yet recruiting

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin Municipality, 300020

    JianXiang Wang, Master, 13821389157, wangjx@ihcams.ac.cn

    Not yet recruiting

  • People's Hospital of Tianjin (City)

    Tianjin, Tianjin Municipality, 300122

    Xingli Zhao, Postdoctoral, 13752255454, tjsrmyyxyk@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Jianhua Qu, Master, 13199855506, jhuaqu@163.com

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    FULING ZHOU, Doctor, 189 8626 5580, zhoufuling@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710000

    PengCheng He, Doctor, 18991232609, hpec_gcp@163.com

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

    Zhen Wang, Master, 13949115270, jenny1983218@126.com

    Not yet recruiting

  • Zhuzhou Central Hospita

    Zhuzhou, Hunan, 412007

    Chanjuan Shen, Master, 18973389928, Shenchanjuan@163.com

    Not yet recruiting

  • Zibo Central Hospital

    Zibo, Shandong, 255036

    Zhencheng Wang, Bachelor, 13905332095, wangzhenchenggcp@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of TQB3909 Tablets in Combination With Azacitidine in Subjects With Myeloid Malignancies

This is an open, multi-center clinical study designed to evaluate the safety, tolerability and efficacy of TQB3909 tablets in combination with azacitidine in subjects with myeloid malignancies.

Being tested
TQB3909 Tablets + Azacitidine

What participants receive

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

  • TQB3909 Tablets + AzacitidineDrug

    TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue

Study groups in NCT07011186
Study groupRoleWhat they receive
TQB3909 Tablets + AzacitidineExperimentalTQB3909 Tablets administered once-daily. 28 days as a treatment cycle.
Receives: Drug: TQB3909 Tablets + Azacitidine

What is being measured

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

  1. Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters

    Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever occurs first)

    Measured: Up to 24 weeks

  2. Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

    Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

    Measured: Up to 4 weeks

Secondary outcomes (14)

  1. Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)

    Proportion of subjects with best response as Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-Free State (MLFS), or Partial Remission (PR)

    Measured: Up to 4 weeks

  2. Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)

    Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR

    Measured: Up to 4 weeks

  3. Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate

    Proportion of subjects with best response as CR+CRi. CRi refers to meeting all CR criteria except for residual neutrophil count decrease (ANC < 1.0 × 109/L) or platelet count decrease (PLT < 100 × 109/L).

    Measured: Up to 4 weeks

  4. Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

    Proportion of subjects with best response as CR

    Measured: Up to 4 weeks

  5. Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate

    Proportion of subjects with best response as CR

    Measured: Up to 4 weeks

  6. Acute Myeloid Leukemia: Duration of Remission (DOR)

    For all subjects with best response as CR, CRi, MLFS, or PR, the time from the first date of achieving remission to the first recorded date of disease progression, relapse, or death (whichever occurs first).

    Measured: Up to 4 weeks

  7. Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh)

    For all subjects with best response as CR or CRh, the time from the first date of achieving CR or CRh to the first recorded date of relapse or death (whichever occurs first).

    Measured: Up to 4 weeks

  8. Acute Myeloid Leukemia: Duration of Complete Remission (DOCR)

    For all subjects with best response as CR, the time from the first date of achieving CR to the first recorded date of relapse or death (whichever occurs first).

    Measured: Up to 4 weeks

  9. Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)

    For all subjects with best response as CR or CRh, the time from the first date of medication to the first date of CR or CRh.

    Measured: Up to 4 weeks

  10. Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)

    For subjects with best response as CR, the time from the first date of medication to the first date of CR.

    Measured: Up to 4 weeks

  11. Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS)

    Defined as the duration from the first dose of medication to treatment failure, relapse after CR or CRi, or death due to any cause (whichever occurs first). Treatment failure is defined as not achieving CR or CRi at any assessment time during treatment. Subjects with treatment failure will be considered to have an EFS event on the first day after the first dose. For subjects with CR or CRi, the event time will be the time of disease relapse or death (whichever occurs first).

    Measured: Up to 4 weeks

  12. Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS)

    The time from the first dose of medication to the date of death due to any cause.

    Measured: Up to 60 weeks

  13. Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate

    Proportion of subjects meeting Hematologic Improvement (HI) criteria, including Hematologic Improvement - Erythrocyte (HI-E), Hematologic Improvement - Platelet (HI-P), and Hematologic Improvement - Neutrophil (HI-N).

    Measured: Up to 4 weeks

  14. Myelodysplastic Syndromes: Transfusion Independence Rate

    The proportion of subjects who did not require transfusions for at least 56 days after baseline, relative to the number of baseline transfusion-dependent and transfusion-independent subjects.

    Measured: Up to 8 weeks

Timeline

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

  1. First posted8 Jun 2025
  2. Study start17 Apr 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2026 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07011186
Sponsor's protocol ID
TQB3909-Ib/II-03
Status last verified
Mar 2025
First submitted
21 May 2025
Last updated
8 Jun 2025
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 TQB3909 Tablets + Azacitidine in people with Myeloid Malignancy, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 21 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

This study is still under way. Results are not available in the source record yet.

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

Contact JianXiang Wang, Master (13821389157, wangjx@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters (time frame: Up to 24 weeks). The study lists 2 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 NCT07011186.

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 8 Jun 2025.

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