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A Clinical Trial of TQB3909 T...

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

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2026-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Myeloid Malignancy

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB3909 Tablets + Azacitidine

TQB3909 Tablets administered once-daily. 28 days as a treatment cycle.

Group Type EXPERIMENTAL

TQB3909 Tablets + Azacitidine

Intervention Type DRUG

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

Interventions

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TQB3909 Tablets + Azacitidine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers