Trial Title:
TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT ID:
NCT06106841
Condition:
Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
400mg of TQB3909 tablets
Description:
TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
Arm group label:
400mg of TQB3909 tablets
Intervention type:
Drug
Intervention name:
600mg of TQB3909 tablets
Description:
TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
Arm group label:
600mg of TQB3909 tablets
Summary:
This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed
or refractory MCL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subject voluntarily joins the study, signs the informed consent form, and has
good compliance;
- Age: ≥ 18 years old (when signing the informed consent form); Eastern Cooperative
Oncology Group performance status (ECOG PS) score: 0-2 points; Expected survival is
more than 3 months;
- Subject population: Confirmed as MCL by local laboratory pathology and independent
pathology review (stage 2).
- The main organs are functioning well,
- The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) shows
measurable lesions, defined as ≥ 1 lymph node with the longest diameter of > 1.5 cm
or ≥ 1 extranodal lesion with the longest diameter of > 1.0 cm, which can be
measured by ≥ 2 vertical dimensions;
- Female subjects of childbearing age should agree to use contraception (e.g., pills,
or condoms) during the study and for 6 months after the end of the study; Have a
negative serum pregnancy test within 7 days prior to study enrollment and must be a
non-lactating subject; Male participants should agree that contraception must be
used during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
- Have had or currently have other malignant tumors within 3 years before the first
dose of study drug.
- It is known that lymphoma affects the central nervous system (CNS);
- Previous allogeneic hematopoietic stem cell transplantation;
- Have received autologous hematopoietic stem cell transplantation within 3 months
before the first dose of study drug;
- There are a variety of factors that affect oral drugs (such as inability to swallow,
chronic diarrhea and intestinal obstruction, inflammatory bowel disease,
malabsorption syndrome, etc.);
- Unmitigated toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade
2 due to any prior treatment (except hair loss, absolute neutrophil count and
platelet abnormalities, which follow the inclusion criteria 4);
- Significant surgical treatment and obvious traumatic injury within 28 days prior to
the start of study treatment;
- Arteriovenous thrombotic events within 3 months before the first dose, such as
cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, except
lacunar cerebral infarction), deep vein thrombosis (except secondary to deep vein
catheterization) and pulmonary embolism;
- Those who have a history of psychotropic substance abuse and cannot be withdrawn or
have mental disorders;
- Subjects with any severe and/or uncontrolled medical conditions, including:
- Grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (Quick Time
Constant Fluctuation (QTcF) >450 ms in men, QTcF >470 ms in women) and grade ≥2
congestive heart failure (New York Heart Association (NYHA) grade), cardiac
ultrasound assessment of left ventricular ejection fraction (LVEF) of <50%; poorly
controlled hypertension, defined as systolic blood pressure > 170 mmHg and diastolic
blood pressure > 105 mmHg at least 2 consecutive blood pressure measurements at the
time of screening；
- presence of active infection (≥ CTCAE grade 2 infection);
- active hepatitis; Hepatitis B virus (HBV) infection, HBV DNA positive or copy number
exceeding the upper limit of normal values in the research center;
- Have a history of immunodeficiency, including Human Immunodeficiency
Virus(HIV)-positive or other acquired or congenital immunodeficiency diseases, or
have a history of organ transplantation;
- Those who have epilepsy and need treatment.
- Have received chemotherapy and radiotherapy within 4 weeks before the first dose,
received immune checkpoint inhibitors and Chimeric Antigen Receptor T-Cell
Immunotherapy (CAR-T) therapy 12 weeks before the first dose, and received other
small molecule antitumor therapy (elution period from the end of the last treatment)
before the first drug use within 5 half-lives;
- Previous treatment with BCL-2 inhibitors;
- Have received a live vaccine within 4 weeks prior to the first dose, or plan to be
vaccinated during the study;
- Have participated in other antitumor drug clinical trials within 4 weeks before the
first dose;
- According to the judgment of the investigator, there are concomitant diseases that
seriously endanger the safety of subjects or affect the completion of the study, or
subjects who are considered to be unsuitable for enrollment for other reasons.
- Allergic to allopurinol and benzbromarone.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing, Doctor
Phone:
15611908428
Email:
bysyjhm@sina.com
Facility:
Name:
Chongqing University Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Liu, Doctor
Phone:
13700986866
Email:
648283926@qq.com
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu, Doctor
Phone:
18750918842
Email:
xubingzhangjian@126.com
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730050
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Cui, Doctor
Phone:
13993162602
Email:
cuijie@csco.org.cn
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Cen, Doctor
Phone:
13507711671
Email:
cen-hong@163.com
Facility:
Name:
The Affiliated Hospital of Chengde Medical College
Address:
City:
Chengde
Zip:
067000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihua Zhang, Doctor
Phone:
15633142905
Email:
zzhangzhihua@163.com
Facility:
Name:
The Second Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Wang, Doctor
Phone:
13604880743
Email:
ww0543@163.com
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang, Doctor
Phone:
13313612989
Email:
nsk86298070@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou, Doctor
Phone:
13674902391
Email:
drzhouks77@163.com
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Zip:
430050
Country:
China
Status:
Recruiting
Contact:
Last name:
Miao Zheng, Doctor
Phone:
13871286124
Email:
zmzk@sina.com
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Nanjing
Zip:
220005
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Zhu, Doctor
Phone:
13852439312
Email:
Frankfeng_2004@126.com
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Recruiting
Contact:
Last name:
Bingzong Li, Bachelor
Phone:
13776054037
Email:
lbzwz0907@hotmail.com
Facility:
Name:
The First Affiliated Hospital Of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin, Bachelor
Phone:
13862553199
Email:
jinzhengming519519@163.com
Facility:
Name:
Jinzhou Central Hospital
Address:
City:
Wuxi
Zip:
530031
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiying Hua, Master
Phone:
15301516125
Email:
huahy007@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Doctor
Phone:
15044044052
Email:
1165095416@qq.com
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130022
Country:
China
Status:
Recruiting
Contact:
Last name:
Ou Bai, Doctor
Phone:
+86 13039046656
Email:
lbl2054@163.com
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiuhua Sun, Doctor
Phone:
+86 17709873631
Email:
3038668@vip.sina.com
Facility:
Name:
Binzhou Medical University Hospital
Address:
City:
Binzhou
Zip:
256603
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenzheng Yu, Doctor
Phone:
13082727089
Email:
bzywz2009@163.com
Facility:
Name:
Linyi People's Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Contact:
Last name:
Guixiang Weng, Master
Phone:
15168965596
Email:
15168965596@163.com
Facility:
Name:
Shanghai Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Tong Chen, Doctor
Phone:
13621778391
Email:
chentong@fudan.edu.cn
Facility:
Name:
Tongji hospital of Tongji University
Address:
City:
Shanghai
Zip:
200065
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xiu, Doctor
Phone:
13381946588
Email:
Xbiubing1233@tongji.edu.com
Facility:
Name:
Heping Hospital Affiliated to Changzhi Medical College
Address:
City:
Changzhi
Zip:
046000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuliang Shen, Doctor
Phone:
13015365546
Email:
shenxlcyp@sohu.com
Facility:
Name:
The Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Zip:
646000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoming Li, Doctor
Phone:
13700986866
Email:
lxm6358@21cn.com
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300040
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihua Qiu, Doctor
Phone:
18622221227
Email:
JZXQLH@163.com
Facility:
Name:
Institute of Dematology & Blood diseases Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu, Doctor
Phone:
+86 13821266636
Email:
Qiulg@ihcams.ac.cn
Facility:
Name:
Xinjiang Uygur Autonomous Region People's Hospital
Address:
City:
Ürümqi
Zip:
830001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Li, Doctor
Phone:
13639935315
Email:
1iyan232917@sina.com
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyan Tong, Doctor
Phone:
13958122357
Email:
hongyantong@aliyun.com
Facility:
Name:
The First Affiliated Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Guifang Ouyang, Doctor
Phone:
13967810405
Email:
nbougf@163.com
Start date:
October 5, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06106841
