TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106841
• Other study ID #: TQB3909-Ib/II-04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Lugui Qiu, Doctor
• Phone: 13821266636
• Email: Qiulg[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• 400mg of TQB3909 tablets
TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
• 600mg of TQB3909 tablets
TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Jilin Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei
China	Chongqing University Hospital	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Gansu Provincial Cancer Hospital	Lanzhou	Gansu
China	Linyi People's Hospital	Linyi	Shandong
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	The Affiliated Hospital of Xuzhou Medical University	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	Shanghai Huashan Hospital	Shanghai	Shanghai
China	Tongji hospital of Tongji University	Shanghai	Shanghai
China	The First Affiliated Hospital Of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Institute of Dematology & Blood diseases Hospital	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Xinjiang Uygur Autonomous Region People's Hospital	Ürümqi	Xinjiang
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
China	Jinzhou Central Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended phase II dose (RP2D)	Recommended phase II dose (RP2D)	Baseline up to 48-weeks
Secondary	The incidence of adverse events (AEs)	Number of participants with adverse events (AE) and/or severe adverse events (SAE) and/or abnormal laboratory examination indicators.	Baseline up to 96-weeks
Secondary	The severity of adverse events (AEs)	The severity of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	Baseline up to 96-weeks
Secondary	The severity of severe adverse events (SAEs)	The severity of severe adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	Baseline up to 96-weeks
Secondary	The severity of abnormal laboratory examination indicators	The severity of abnormal laboratory examination indicators as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.	Baseline up to 96-weeks