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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a new medication called TQB3909 tablets, combined with another drug called azacitidine, to treat certain blood cancers known as myeloid malignancies, which include conditions like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). The main goals of the study are to see how safe and effective this combination treatment is for patients. The trial is currently recruiting participants who are at least 18 years old and have a life expectancy of over three months.

To join the trial, participants need to be diagnosed with one of the specified blood cancers and have normal major organ functions. They should also be willing to use contraception during the study and for six months after it ends if they can become pregnant. Participants will be closely monitored for their health and any side effects during the study. It’s important to note that certain health conditions or recent medical histories may exclude someone from participating, such as having another cancer within the last three years or serious health issues that could affect treatment. Overall, this trial aims to explore new treatment options for patients facing challenging myeloid malignancies.

Gender

ALL

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.