Acute Myeloid LeukemiaPhase 1/2NCT06218771
A Study of TQB3454 Tablets in Patients With Blood Tumors
A Phase 1/2 study testing TQB3454 Tablets in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- TQB3454 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 17 sitesChina
- Study dates
- 10 Jul 2023to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily joined the study and signed informed consent with good compliance.
- Men and women; The expected survival is ≥3 months.
- Negative serum/urine pregnancy test within 7 days prior to initial dose and must be non-lactating; Women of childbearing age agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study and for six months after the study completion; Men agreed to use contraception during the study period and for six months after the end of the study.
- The major organs are functioning well;
- For Relapsing/refractory acute myeloid leukemia (AML):
- According to the classification criteria for Hematopoietic and lymphoid tissue tumors revised by the World Health Organization (WHO) in 2016, AML confirmed by bone marrow cell morphology, excluding acute promyelocytic leukemia (APL).
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- ≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0~2.
- Blood biochemical examination:
- i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases; ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if liver infiltration was associated.
- For myelodysplastic syndrome (MDS) with higher risk:
- MDS patients were confirmed by bone marrow cell morphology and cytogenetics and met the classification criteria of hematopoietic and lymphoid tissue tumors revised by WHO in 2016.
- ≥18 years old; ECOG score is 0~2. c. Blood biochemical examination:
- i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases.
- ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if concomitant with liver infiltration.
Who cannot join
- Tumor diseases and history:
- The tumor has or is suspected to involve the central nervous system, or primary Central nervous system leukemia.
- Present or present with other malignant tumors within 3 years prior to the first dose. Except the following conditions: for other malignancies treated with a single operation, achieving a 5-year continuous disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)].
- Severe life-threatening complications of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.
- Previous antitumor therapy:
- Received National Medical Products Administration (NMPA) approved Chinese patent drugs with anticancer indications specified in the drug label within 2 weeks prior to initial administration.
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- Toxicities associated with previous antineoplastic therapy did not return to CTCAE≤1, except for hair loss, fatigue and poor appetite.
- 3. Associated diseases and history:
- <!-- -->
- Abnormal liver.
- Renal abnormalities.
- Gastrointestinal abnormalities.
- Cardio-cerebrovascular abnormalities.
- Immune-related history.
- Lung disease.
- Comorbidities that were severe or poorly controlled and, in the investigator's judgment, significantly compromised patient safety or hindered study completion.
- Risk of bleeding.
- History of drug abuse or drug abuse.
- Participated in clinical trials of other drugs within the past 30 days;
- It is estimated that the patient's compliance to participate in this clinical study is insufficient.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Junfeng Zhu, Master, 15215526662, zhujunfeng517@163.com
- Recruiting
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, 264008
Wenzheng Yu, Doctor, 13082727089, bzywz2009@163.com
- Recruiting
Cangzhou people's Hospital
Cangzhou, Hebei, 061000
Hongmei Ma, Bachelor, 18031798229, mhm-sspc@163.com
- Recruiting
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000
Zhihua Zhang, Doctor, 15633142905, zzhangzhihua@163.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Yong Guo, Doctor, 13551321632, 1597949593@qq.com
- Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200000
Ligen Liu, Master, 18017337037, Liuligen@medmail.com.cn
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Xiaoqing Wang, Doctor, 13621851543, wangxiaoqin@shmu.edu.cn
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Siguo Hao, Doctor, 15301655537, hosghj88@hotmail.com
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Chunkang Chang, Master, 13764643870, changchunkang7010@aliyun.com
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Wenwei Zhu, Doctor, 18930565525, wwz3006@163.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Suning Chen, Doctor, 13814881746, chensuning@sina.com
- Recruiting
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Tiejun Qin, Master, 13332095356, qintiejun@ihcams.ac.cn
- Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yu Hu, Doctor, 027-85726685, dr.huyu@126.com
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Xin Zhou, Bachelor, 0510-85350202, zx89232@126.com
- Recruiting
Yantai Mountain Hospital
Yantai, Shandong, 264008
Dongmei Zhou, Bachelor, 0535-6863845, zhoudongmei68@163.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264008
Xiaoxia Chu, Master, 18660515179, lucychu66@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Xundong Wei, Doctor, 13837169301, weixudong63@126.com
About this study
Official title: A Phase Ib Clinical Trial of TQB3454 Tablets in Patients With Blood Tumors
The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- TQB3454 Tablets
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3454 TabletsDrug
TQB3454 Tablets is a selective isocitrate dehydrogenase 1 (IDH1) mutation inhibitor
| Study group | Role | What they receive |
|---|---|---|
| TQB3454 Tablets | Experimental | TQB3454 Tablets, orally administered, 28 days as a treatment cycle. Receives: Drug: TQB3454 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of all adverse events (AEs), serious adverse events (SAEs)
Proportion of patients with adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
Measured: Up to 80 weeks
The severity of all adverse events (AEs), serious adverse events (SAEs)
The severity of adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
Measured: Up to 80 weeks
Incidence of abnormal laboratory values
The proportion of patients with abnormal laboratory examination indicators mainly included blood routine, blood routine, blood biochemistry, coagulation function, thyroid function, myocardial enzyme profile, urine routine, stool routine and 12-lead electrocardiogram.
Measured: Up to 80 weeks
Secondary outcomes (20)
Peak time (Tmax)
The time required to reach peak concentration after administration.
Measured: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Peak concentration (Cmax)
the maximum plasma concentration of the drug after administration.
Measured: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Area under blood concentration-time curve (AUC 0-24h)
The area surrounded by the blood concentration curve to the time axis.
Measured: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Steady-state apparent volume of distribution (Vz/F)
The volume of distribution at steady-state concentration.
Measured: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Steady-state blood trough concentration (Cmin,ss)
the lowest concentration during dosing and is usually obtained from the initial moment after dosing to the lowest concentration before the next dosing when multiple dosing reaches steady-state.
Measured: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Complete response (CR) rate
The proportion of patients with an optimal response of CR.
Measured: Up to 80 weeks
Complete response (CR) + Complete response with partial hematological recovery (CRh)
Proportion of patients with optimal response of CR and CRh
Measured: Up to 80 weeks
Transfusion-independent improvement
Proportion of transfusion-dependent patients at baseline who were removed from red blood cell (RBC) or platelet transfusion dependence after randomization.
Measured: Up to 80 weeks
CR+CRh duration
In all patients with an optimal response of CR or CRh, the time from the date when CR or CRh was first achieved to the date of first clearly documented disease progression / relapse / treatment failure or death, whichever occurs first.
Measured: Up to 80 weeks
CR duration
For all patients with an optimal response of CR, the time from the date when CR was first achieved to the first clearly documented date of disease progression/relapse/treatment failure or death, whichever occurs first.
Measured: Up to 80 weeks
Duration of response (DOR)
The time from the date of first remission to the date of first clearly documented disease progression/relapse/treatment failure or date of death in all patients with optimal response of CR, CR with incomplete blood count recovery(CRi), CR with incomplete platelet recovery (CRp), Morphologic Leukemia-free state (MLFS), or Partial Remission (PR), whichever occurs first.
Measured: Up to 80 weeks
Time to CR+CRh
Time from the date of first TQB3454 dose to the date of first CR or CRh in all patients with optimal response to CR or CRh.
Measured: Up to 80 weeks
Event-free survival (EFS)
The time from the date of the first dose TQB3454 tablet to the first clearly documented date of relapse after disease remission, disease progression/treatment failure, or death, whichever occurs first.
Measured: Up to 80 weeks
Overall survival (OS)
Time from the date of first dose of TQB3454 tablet to the date of death from any cause.
Measured: Up to 80 weeks
Functional Assessment of Chronic Illness (FACIT) fatigue Scale
Proportion of patients with a confirmed improvement of at least 3 points from baseline in FACit-Fatigue scale scores.
Measured: Up to 80 weeks
Quality of life score
Proportion of patients with a confirmed improvement of at least 10 points from baseline in their overall health as assessed by European organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Measured: Up to 80 weeks
Overall response rate (ORR)
Proportion of patients with an optimal response of CR, marrow CR (mCR), PR, or Hematology improvement (HI).
Measured: Up to 80 weeks
Progression-free survival (PFS)
from the date of first dose of TQB3454 tablet to the time of first recorded disease progression assessed by the investigator or relapse after CR or death from any cause. Disease progression includes acute leukaemia transformation.
Measured: Up to 80 weeks
Leukemia-free survival
from the date of first dose of TQB3454 tablet to the time of >20% original cells in bone marrow/peripheral blood, or diagnosis of acute extramedullary leukemia, or death from any cause.
Measured: Up to 80 weeks
Correlation between 2-hydroxyglutaric acid (2-HG) and efficacy
Liquid chromatography-mass spectrometry (LC-MS/MS) was used to determine 2-HG in plasma and to analyze its correlation with efficacy.
Measured: Pre-dose (baseline). Pre-dose on Cycle 1 Day 14, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, Cycle 4 Day 28, Cycle 5 Day 28, Cycle 6 Day 28, 28 days as a cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start10 Jul 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218771
- Sponsor's protocol ID
- TQB3454-Ib-01
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Trial of TQB3454 Tablets in Patients With Blood Tumors
- ClinicalTrials.gov ID
- NCT06218771
- Acronym / sponsor ID
- TQB3454-Ib-01
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the safety of TQB3454 tablets in patients with acute myeloid leukemia and myelodysplastic syndrome, and determine the phase II recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3454 Tablets | Experimental | Drug: TQB3454 TabletsTQB3454 Tablets, orally administered, 28 days as a treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients voluntarily joined the study and signed informed consent with good compliance.
- Men and women; The expected survival is ≥3 months.
- Negative serum/urine pregnancy test within 7 days prior to initial dose and must be non-lactating; Women of childbearing age agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study and for six months after the study completion; Men agreed to use contraception during the study period and for six months after the end of the study.
- The major organs are functioning well;
- For Relapsing/refractory acute myeloid leukemia (AML):
Key exclusion criteria (20 listed)
- Tumor diseases and history:
- Previous antitumor therapy:
- <!-- -->
- History of drug abuse or drug abuse.
- Participated in clinical trials of other drugs within the past 30 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3454 TabletsTQB3454 Tablets is a selective isocitrate dehydrogenase 1 (IDH1) mutation inhibitor | Drug | TQB3454 Tablets |
Primary outcome
The rate of all adverse events (AEs), serious adverse events (SAEs)
Time frame: Up to 80 weeks
Proportion of patients with adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
The severity of all adverse events (AEs), serious adverse events (SAEs)
Time frame: Up to 80 weeks
The severity of adverse events/serious adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE5.0)
Incidence of abnormal laboratory values
Time frame: Up to 80 weeks
The proportion of patients with abnormal laboratory examination indicators mainly included blood routine, blood routine, blood biochemistry, coagulation function, thyroid function, myocardial enzyme profile, urine routine, stool routine and 12-lead electrocardiogram.
20 secondary outcomes
Peak time (Tmax)
Time frame: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Peak concentration (Cmax)
Time frame: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Area under blood concentration-time curve (AUC 0-24h)
Time frame: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Steady-state apparent volume of distribution (Vz/F)
Time frame: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Steady-state blood trough concentration (Cmin,ss)
Time frame: Cohort 1: pre-dose on Day 1, 14, 28 of Cycle 1, Day 14, 28 of Cycle 2. 2, 3, 4, 10, 24 hours after dose on Cycle1 Day28. Cohort 2: pre-dose, 2, 3, 4, 10, 24 hours after dose on Day 1, 28 of Cycle 1. Pre-dose on Day 14, 28 of Cycle2. 28 days as a cycle.
Complete response (CR) rate
Time frame: Up to 80 weeks
Complete response (CR) + Complete response with partial hematological recovery (CRh)
Time frame: Up to 80 weeks
Transfusion-independent improvement
Time frame: Up to 80 weeks
CR+CRh duration
Time frame: Up to 80 weeks
CR duration
Time frame: Up to 80 weeks
Duration of response (DOR)
Time frame: Up to 80 weeks
Time to CR+CRh
Time frame: Up to 80 weeks
Event-free survival (EFS)
Time frame: Up to 80 weeks
Overall survival (OS)
Time frame: Up to 80 weeks
Functional Assessment of Chronic Illness (FACIT) fatigue Scale
Time frame: Up to 80 weeks
Quality of life score
Time frame: Up to 80 weeks
Overall response rate (ORR)
Time frame: Up to 80 weeks
Progression-free survival (PFS)
Time frame: Up to 80 weeks
Leukemia-free survival
Time frame: Up to 80 weeks
Correlation between 2-hydroxyglutaric acid (2-HG) and efficacy
Time frame: Pre-dose (baseline). Pre-dose on Cycle 1 Day 14, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, Cycle 4 Day 28, Cycle 5 Day 28, Cycle 6 Day 28, 28 days as a cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB3454 Tablets in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Hu, Doctor (027-85726685, dr.huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of all adverse events (AEs), serious adverse events (SAEs) (time frame: Up to 80 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.