A Phase Ib/II Clinical Trial of TQB3909 Tablets in Subjects With Relapsed or Refractory MCL Safety and Efficacy

Status: Unknown
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Binzhou Medical University Hospital
RECRUITING
Binzhou
Jilin Cancer Hospital
RECRUITING
Changchun
The First Hospital of Jilin University
RECRUITING
Changchun
Heping Hospital Affiliated to Changzhi Medical College
RECRUITING
Changzhi
The Affiliated Hospital of Chengde Medical College
RECRUITING
Chengde
Chongqing University Hospital
RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Affiliated Cancer Hospital of Harbin Medical University
RECRUITING
Harbin
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
Linyi People's Hospital
RECRUITING
Linyi
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Shanghai Huashan Hospital
RECRUITING
Shanghai
Tongji hospital of Tongji University
RECRUITING
Shanghai
The First Affiliated Hospital Of Soochow University
RECRUITING
Suzhou
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Dematology & Blood diseases Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Xinjiang Uygur Autonomous Region People's Hospital
RECRUITING
Ürümqi
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING
Wuhan
Jinzhou Central Hospital
RECRUITING
Wuxi
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Lugui Qiu, Doctor
Qiulg@ihcams.ac.cn
13821266636
Time Frame
Start Date: 2023-10-05
Completion Date: 2024-12
Participants
Target number of participants: 39
Treatments
Experimental: 400mg of TQB3909 tablets
tablet, 28 days as a treatment cycle.
Experimental: 600mg of TQB3909 tablets
tablet, 28 days as a treatment cycle.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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