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NCT Number: NCT07011186

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

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Key information

Conditions

Myeloid Malignancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

TQB3909 Tablets + Azacitidine

Drug

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

Primary outcomes

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

    Time frame: Up to 24 weeks

    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)

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

    Time frame: Up to 4 weeks

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

Secondary outcomes

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

    Time frame: Up to 4 weeks

    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)

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

    Time frame: Up to 4 weeks

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

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

    Time frame: Up to 4 weeks

    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).

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

    Time frame: Up to 4 weeks

    Proportion of subjects with best response as CR

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

    Time frame: Up to 4 weeks

    Proportion of subjects with best response as CR

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

    Time frame: Up to 4 weeks

    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).

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

    Time frame: Up to 4 weeks

    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).

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

    Time frame: Up to 4 weeks

    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).

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

    Time frame: Up to 4 weeks

    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.

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

    Time frame: Up to 4 weeks

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

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

    Time frame: Up to 4 weeks

    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).

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

    Time frame: Up to 60 weeks

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

  13. Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate

    Time frame: Up to 4 weeks

    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).

  14. Myelodysplastic Syndromes: Transfusion Independence Rate

    Time frame: Up to 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

JianXiang Wang, Master

CONTACT

[email protected]

13821389157

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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