Chronic Lymphocytic LeukemiaPhase 1/2NCT05959694
A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .
A Phase 1/2 study testing TQB3909 tablet in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 sites in China.
Trial summary
This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- TQB3909 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 25 sitesChina
- Study dates
- 11 Oct 2023to Jun 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects volunteered to join the study and signed informed consent form (ICF) with good compliance;
- Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
- Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
- Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
- Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;
Who cannot join
- Complicated diseases and medical history:
- It has appeared or is currently suffering from other malignant tumors within 3 years before the first medication. The following two situations can be included in the group: other malignant tumors treated by single surgery have achieved disease-free survival (DFS) for five consecutive years; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Lymphoma/leukemia is known to involve the central nervous system (CNS);
- Previously received allogeneic hematopoietic stem cell transplantation;
- Received autologous hematopoietic stem cell transplantation within 3 months before the first medication;
- Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
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- Arterial/venous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- Subjects with any serious and/or uncontrollable diseases;
- Tumor-related symptoms and treatment:
- He has received chemotherapy and radiotherapy within 4 weeks before the first medication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and other small molecule anti-tumor treatments (the elution period is calculated from the end of the last treatment) before the first medication are within 5 half-lives;
- previously received BCL-2 inhibitors;
- Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;
- Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;
- According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.
- Allergic to allopurinol and benzbromarone.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites, 25 recruiting
- Recruiting
Anqing Municipal Hospital
Anqing, Anhui, 246004
Fusheng Yao, Doctor, 18955682626, yfsh3792@sina.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410029
Yajun Li, Doctor, 19918803330, 158316115@qq.com
- Recruiting
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 460000
Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com
- Recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067400
Zhihua Zhang, Master, 156333142905, zzhangzhihua@163.com
- Recruiting
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, 510060
Zhiming Li, Doctor, +86 13719189172, lzmlzmlzm@yahoo.com
- Recruiting
Harbin first hospital
Harbin, Heilongjiang, 150000
Tiejun Gong, Master, 13836027737, arc@sina.con
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Wang Wei, Doctor, 13604880743, WW0543@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
Jie Li, Doctor, 18560082232, jieli6688@163.com
- Recruiting
Linyi people's hospital
Linyi, Shandong, 276002
Haiyan Zhang, Master, 13869986288, 13869986288@163.com
- Recruiting
Affiliated hospital of southwest medical university
Luzhou, Sichuan, 646000
Xiaoming Li, Master, 13700986866, LXM6358@21.com.cn
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Xiaobo Du, Doctor, 13550822229, Duxiaobo2005@126.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Wuping Li, Doctor, 13870659916, 18907001021@163.com
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Jianyong Li, Doctor, +8613951877733, Ljianyonglm@mcdmail.com
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Guifang Ouyang, Master, 13967810405, nbougf@163.com
- Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200050
Ligen Liu, Master
- Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000
Wei Yang, Doctor, 18940251012, yangw@sj-hospital.org
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Bingzong Li, Doctor, 13776054037, lbzwz0907@hotmail.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, Bachelor, 13862553199, jinzhengming519519@163.com
- Recruiting
Tai 'an Central Hospital
Tai’an, Shandong, 271000
Qingliang Teng, Master, 13375388422, tatql@163.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Yafei Wang, Doctor, 18622221250, Drwang2005@163.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830054
Jianhua Qu, Master, 13199855506, jhuaqu@163.com
- Recruiting
Gansu province Wuwei tumour hospital
Wuwei, Gansu, 733000
Cong Wang, Bachelor, 13893510690, 58589473@qq.com
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Feng Zhu, Doctor, 13852439312, Frankfeng_2004@126.com
- Recruiting
Yibin Second People's Hospital
Yibin, Sichuan, 644000
Sihua Huang, Bachelor, 18284820022
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Keshu Zhou, Doctor, +86 13674902391, drzhouks77@163.com
About this study
Official title: A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.
This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.
- Being tested
- TQB3909 tablet
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3909 tabletDrug
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
| Study group | Role | What they receive |
|---|---|---|
| TQB3909 tablets | Experimental | Oral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears. Receives: Drug: TQB3909 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Severity of adverse events (AE)
Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Incidence of serious adverse events (SAE)
Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Severity of serious adverse events (SAE)
Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Incidence of abnormal laboratory examination indexes.
Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Severity of abnormal laboratory examination indexes.
Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Measured: Up to 34 months.
Recommended phase II dose (RP2D)
To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.
Measured: Up to 18 months
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
Determine the objective remission rate (ORR) based on the evaluation results of the Independent Review Committee (IRC), defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
Measured: Up to 34 months
Secondary outcomes (12)
Objective remission rate (ORR) determined by the investigators' evaluation.
The objective remission rate (ORR) was determined by the results of the investigator s' evaluation, defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
Measured: Up to 34 months
Duration of remission (DOR)
For all subjects whose best response was PR, CR,, the time from the date of first achieving PR, CR to the date of first definite disease progression or death from any cause (whichever occurs first).
Measured: Up to 34 months
Time to disease progression (TTP)
Refers to the time from the first medication to the objective progress of the disease.
Measured: Up to 34 months
Time to remission (TTR)
Time from the beginning of treatment to the first recording of remission (PR or better remission), only the remission population was analyzed.
Measured: Up to 34 months
Progression-free survival (PFS)
The time from the first medication to the objective progression of the disease or death caused from any cause (whichever comes first).
Measured: Up to 34 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Measured: Up to 34 months
Time to reach maximum concentration (Tmax)
Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets.
Measured: Within 120 hours after administration
Maximum plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3909.
Measured: Within 120 hours after administration
Area under the plasma concentration-time curve (AUC0-t)
To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve.
Measured: Within 120 hours after administration
Plasma elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.
Measured: Within 120 hours after administration
Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow.
Refers to the undetected residual lesions. Peripheral blood and/or bone marrow are used to detect less than 1 CLL cell (less than 10-4) in 10000 white blood cells by flow cytometry.
Measured: Up to 34 months
Correlation between potential biomarkers and TQB3909 tablets.
Correlation of potential biomarkers with TQB3909 tablets: such as BTK and PLCG2 mutation status and allele frequency.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start11 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic 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
- 107 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
- NCT05959694
- Sponsor's protocol ID
- TQB3909-Ib/II-02
- Status last verified
- Jun 2023
- First submitted
- 17 Jul 2023
- Last updated
- 23 Oct 2023
- 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 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.
- ClinicalTrials.gov ID
- NCT05959694
- Acronym / sponsor ID
- TQB3909-Ib/II-02
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jul 2023 (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 is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3909 tablets | Experimental | Drug: TQB3909 tabletOral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects volunteered to join the study and signed informed consent form (ICF) with good compliance;
- Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
- Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
- Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
- Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;
Key exclusion criteria (15 listed)
- Complicated diseases and medical history:
- Tumor-related symptoms and treatment:
- Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;
- Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;
- According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.
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 |
|---|---|---|
| TQB3909 tabletTQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. | Drug | TQB3909 tablets |
Primary outcome
Incidence of adverse events (AE)
Time frame: Up to 34 months.
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of adverse events (AE)
Time frame: Up to 34 months.
Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Incidence of serious adverse events (SAE)
Time frame: Up to 34 months.
Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of serious adverse events (SAE)
Time frame: Up to 34 months.
Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Incidence of abnormal laboratory examination indexes.
Time frame: Up to 34 months.
Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Severity of abnormal laboratory examination indexes.
Time frame: Up to 34 months.
Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Recommended phase II dose (RP2D)
Time frame: Up to 18 months
To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
Time frame: Up to 34 months
Determine the objective remission rate (ORR) based on the evaluation results of the Independent Review Committee (IRC), defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
12 secondary outcomes
Objective remission rate (ORR) determined by the investigators' evaluation.
Time frame: Up to 34 months
Duration of remission (DOR)
Time frame: Up to 34 months
Time to disease progression (TTP)
Time frame: Up to 34 months
Time to remission (TTR)
Time frame: Up to 34 months
Progression-free survival (PFS)
Time frame: Up to 34 months
Overall survival (OS)
Time frame: Up to 34 months
Time to reach maximum concentration (Tmax)
Time frame: Within 120 hours after administration
Maximum plasma drug concentration (Cmax)
Time frame: Within 120 hours after administration
Area under the plasma concentration-time curve (AUC0-t)
Time frame: Within 120 hours after administration
Plasma elimination half-life (t1/2)
Time frame: Within 120 hours after administration
Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow.
Time frame: Up to 34 months
Correlation between potential biomarkers and TQB3909 tablets.
Time frame: Up to 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
25 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 TQB3909 tablet in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 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 5 inclusion and 15 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 Jianyong Li, Doctor (+86 13951877733, Ljianyonglm@mcdmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE) (time frame: Up to 34 months.). The study lists 8 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 Oct 2023.