Status:

RECRUITING

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

Lead Sponsor:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Conditions:

Myeloid Malignancy

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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.

Eligibility Criteria

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:

    1. Acute Myeloid Leukemia (AML):
    2. Myelodysplastic Syndromes (MDS)
    3. Major organ functions are normal.
    4. 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:

    1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
    2. Presence of multiple factors affecting oral drug intake and/or absorption;
    3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
    4. History of arterial/venous thrombotic events within 6 months prior to the first dose;
    5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
    6. Presence of any severe and/or uncontrolled disease in the subject.
  • Tumor-related Symptoms and Treatment:

    1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
    2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
    3. Subjects with extramedullary disease only in AML;
    4. Presence of life-threatening severe leukemia-related complications;
  • Study Treatment-related:

    1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
    2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.

Key Trial Info

Start Date :

April 17 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT07011186

Start Date

April 17 2024

End Date

October 1 2026

Last Update

June 8 2025

Active Locations (21)

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Page 1 of 6 (21 locations)

1

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China, 233000

2

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China, 100020

3

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

4

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China, 102218