NCT07011186 A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
| NCT ID | NCT07011186 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Condition | Myeloid Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 138 participants in total. It began in 2024-04-17 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07011186 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloid Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07011186 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07011186 currently recruiting?
Yes, NCT07011186 is actively recruiting participants. Contact the research team at wangjx@ihcams.ac.cn for enrollment information.
Where is the NCT07011186 trial being conducted?
This trial is being conducted at Bengbu, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07011186 clinical trial?
NCT07011186 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. The trial plans to enroll 138 participants.