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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05959694
Other study ID # TQB3909-Ib/II-02
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 11, 2023
Est. completion date June 2026

Study information

Verified date June 2023
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Jianyong Li, Doctor
Phone +86 13951877733
Email Ljianyonglm@mcdmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 107
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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; Exclusion Criteria: - Complicated diseases and medical history: 1. 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)]; 2. Lymphoma/leukemia is known to involve the central nervous system (CNS); 3. Previously received allogeneic hematopoietic stem cell transplantation; 4. Received autologous hematopoietic stem cell transplantation within 3 months before the first medication; 5. Unresolved toxic reaction = CTCAE grade 1 caused by any previous treatment; 6. 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; 7. Subjects with any serious and/or uncontrollable diseases; - Tumor-related symptoms and treatment: 1. 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; 2. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TQB3909 tablet
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.

Locations

Country Name City State
China Anqing Municipal Hospital Anqing Anhui
China Hunan Cancer Hospital Changsha Hunan
China Peace Hospital Affiliated to Changzhi Medical College Changzhi Shanxi
China Affiliated Hospital of Chengde Medical College Chengde Hebei
China Sun Yat-Sen University Cancer Canter Guangzhou Guangdong
China Harbin first hospital Harbin Heilongjiang
China The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China Qilu Hospital of Shandong University Jinan Shandong
China Linyi people's hospital Linyi Shandong
China Affiliated hospital of southwest medical university Luzhou Sichuan
China Mianyang Central Hospital Mianyang Sichuan
China Jiangxi Cancer Hospital Nanchang Jiangxi
China Jiangsu Provincial People's Hospital Nanjing Jiangsu
China The First Affiliated Hospital of Ningbo University Ningbo Zhejiang
China Shanghai Tongren Hospital Shanghai Shanghai
China Shengjing Hospital Affiliated to China Medical University Shenyang Liaoning
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China Tai 'an Central Hospital Tai'an Shandong
China Tianjin Cancer Hospital Tianjin Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Uygur Autonomous Region
China Gansu province Wuwei tumour hospital Wuwei Gansu
China Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China Yibin Second People's Hospital Yibin Sichuan
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AE) Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0). Up to 34 months.
Primary Severity of adverse events (AE) Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0). Up to 34 months.
Primary Incidence of serious adverse events (SAE) Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0). Up to 34 months.
Primary Severity of serious adverse events (SAE) Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0). Up to 34 months.
Primary 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). Up to 34 months.
Primary 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). Up to 34 months.
Primary Recommended phase II dose (RP2D) To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL. Up to 18 months
Primary 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). Up to 34 months
Secondary 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). Up to 34 months
Secondary 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). Up to 34 months
Secondary Time to disease progression (TTP) Refers to the time from the first medication to the objective progress of the disease. Up to 34 months
Secondary 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. Up to 34 months
Secondary 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). Up to 34 months
Secondary Overall survival (OS) Time from first dose of study drug to date of death from any cause. Up to 34 months
Secondary Time to reach maximum concentration (Tmax) Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets. Within 120 hours after administration
Secondary Maximum plasma drug concentration (Cmax) Cmax is the maximum plasma concentration of TQB3909. Within 120 hours after administration
Secondary 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. Within 120 hours after administration
Secondary Plasma elimination half-life (t1/2) t1/2 is time it takes for the blood concentration of TQB3909 to drop by half. Within 120 hours after administration
Secondary 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. Up to 34 months
Secondary Correlation between potential biomarkers and TQB3909 tablets. Correlation of potential biomarkers with TQB3909 tablets: such as BTK and PLCG2 mutation status and allele frequency. Up to 34 months
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