Acute Myeloid Leukemia (AML)Phase 1NCT06550713
A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies
A Phase 1 study testing TQB3455 tablet+Azacitidine for Injection in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites in China.
Trial summary
This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- What is being tested?
- TQB3455 tablet+Azacitidine for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesChina
- Study dates
- 22 Oct 2019to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 meeting all of the following inclusion criteria can be included in this trial:
- Age ≥ 18 years old;
- According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:
- Difficult to treat or recurrent (>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
- Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group)
- MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):
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- Extremely high-risk (>6 points)
- High risk (>4.5 points - ≤ 6 points)
- Medium risk (>3 points - ≤ 4.5 points)
- Clearly indicating the presence of IDH2 gene mutation;
- Blood platelet (PLT) ≥20×10^9/L； Or subjects with PLT<20 × 10^9/L, but recognized by the researchers as being caused by tumor reasons;
- Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN);
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min;
- Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I;
- Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period;
- The subjects voluntarily joined this study.
Who cannot join
- Subjects who experience relapse after bone marrow transplantation;
- Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
- Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
- Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
- Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors;
- The subject has uncontrolled systemic fungal, bacterial, or viral infections;
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- High blood pressure subjects who are still poorly controlled despite drug treatment;
- Obvious cardiovascular diseases, such as heart failure classified as grade 2 or above by the New York Heart Association (NYHA), unstable angina in the past 3 months, myocardial ischemia or infarction, arrhythmia and grade I heart failure, or the presence of other factors at risk of prolonging the QT interval (such as arrhythmia, hypokalemia ≥ grade 3, family history of long QT interval);
- Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation;
- Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Subjects with active replication of hepatitis B virus and hepatitis C virus;
- Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete the study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wenbing Duan, Master contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Hao Jiang, Master, 13601164350, 2516735116@qq.com
- Not yet recruiting
Peking University international Hospital
Beijing, Beijing Municipality, 102206
Min Ouyang, Doctor, 13522691907, ouyangmin@pkuih.edu.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Hongbing Ma, Doctor, 18980605801, hongbingma@foxmail.com
- Not yet recruiting
Harbin The First Hospital
Harbin, Heilongjiang, 150010
Tiejun Gong, Master, 13836027737, arc@sina.con
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 201306
Chunkang Chang, Doctor, 18930177640, changchunkang@sina.com
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xuejun Zhang, Doctor, 13722781112, zhxjhbmu@126.com
Zhiqing Zhang, Doctor, 15803210627, 777yyy@sina.com
- Not yet recruiting
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, 300121
Xingli Zhao, Postdoc, 13752255454, tjsrmyyxyk@163.com
About this study
Official title: Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies
This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- Being tested
- TQB3455 tablet+Azacitidine for Injection
- 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.
TQB3455 tablet+Azacitidine for InjectionDrug
TQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a cytosine nucleoside drug that is used for demethylation therapy.
| Study group | Role | What they receive |
|---|---|---|
| TQB3455 tablet and Azacitidine for Injection | Experimental | Stage1：TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle.
Stage2：TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle.
Azacitidine for injection: A treatment cycle of 4 weeks, with subcutaneous injection of Azacitidine standard dose on the first to seventh day of each cycle. Receives: Drug: TQB3455 tablet+Azacitidine for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Measured: Baseline up to 28 days
The maximum tolerated dose (MTD)
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Measured: Up to 48 weeks
Overall Remission Rate
The number of participants with CR + incomplete recovery (CRi) + incomplete platelet recovery (CRp) according to modified International Working Group Acute Myeloid Leukemia (IWG AML) response criteria.
Measured: Up to 48 weeks
Secondary outcomes (7)
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Measured: U to 96 weeks
Duration of Response (DOR)
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Measured: Up to 48 weeks
Complete Remission Rate
The number of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML).
Measured: Up to 48 weeks
Cmax
Cmax is the maximum plasma concentration of TQB3455 or metabolite(s).
Measured: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
Tmax
To characterize the pharmacokinetics of TQB3455 by assessment of time to reach maximum plasma concentration.
Measured: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
Area Under the Curve (AUC) 0-t
To characterize the pharmacokinetics of TQB3455 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0,0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
α-Hydroxyglutaric acid (2-HG)
The concentration of 2-HG.
Measured: Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 ; Day 1 pre-dose on multiple dose from cycle 3 to cycle 8. Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start22 Oct 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06550713
- Sponsor's protocol ID
- TQB3455-I-01
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2022
- Last updated
- 13 Aug 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT06550713
- Acronym / sponsor ID
- TQB3455-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 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.
This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3455 tablet and Azacitidine for Injection | Experimental | Drug: TQB3455 tablet+Azacitidine for InjectionStage1：TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle. Stage2：TQB3455 tablet, oral, once a day, for 28 consecutive days as a treatment cycle. Azacitidine for injection: A treatment cycle of 4 weeks, with subcutaneous injection of Azacitidine standard dose on the first to seventh day of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years old;
- According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:
- MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):
- Clearly indicating the presence of IDH2 gene mutation;
- Blood platelet (PLT) ≥20×10^9/L； Or subjects with PLT<20 × 10^9/L, but recognized by the researchers as being caused by tumor reasons;
Key exclusion criteria (14 listed)
- Subjects who experience relapse after bone marrow transplantation;
- Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
- Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
- Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
- Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors;
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 |
|---|---|---|
| TQB3455 tablet+Azacitidine for InjectionTQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a cytosine nucleoside drug that is used for demethylation therapy. | Drug | TQB3455 tablet and Azacitidine for Injection |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
The maximum tolerated dose (MTD)
Time frame: Up to 48 weeks
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Overall Remission Rate
Time frame: Up to 48 weeks
The number of participants with CR + incomplete recovery (CRi) + incomplete platelet recovery (CRp) according to modified International Working Group Acute Myeloid Leukemia (IWG AML) response criteria.
7 secondary outcomes
Overall survival (OS)
Time frame: U to 96 weeks
Duration of Response (DOR)
Time frame: Up to 48 weeks
Complete Remission Rate
Time frame: Up to 48 weeks
Cmax
Time frame: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
Tmax
Time frame: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
Area Under the Curve (AUC) 0-t
Time frame: Hour 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12, 24, 48, 96, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day 22 on multiple dose and hour 0,0.25, 0.5, 1, 2, 3, 5, 8, 12, 24 hours post-dose on multiple dose of day 28
α-Hydroxyglutaric acid (2-HG)
Time frame: Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 ; Day 1 pre-dose on multiple dose from cycle 3 to cycle 8. Each cycle is 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
Wenbing Duan, Master contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3455 tablet+Azacitidine for Injection in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Jiang, Master (13601164350, 2516735116@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days). 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 13 Aug 2024.