Clinical trial NCT06106841: TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Official title: A Phase Ib/II Clinical Trial of TQB3909 Tablets in Subjects With Relapsed or Refractory MCL Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Recommended phase II dose (RP2D)
timeFrame: Baseline up to 48-weeks
Secondary outcomes:
measure: The incidence of adverse events (AEs)
timeFrame: Baseline up to 96-weeks
measure: The severity of adverse events (AEs)
timeFrame: Baseline up to 96-weeks
measure: The severity of severe adverse events (SAEs)
timeFrame: Baseline up to 96-weeks
measure: The severity of abnormal laboratory examination indicators
timeFrame: Baseline up to 96-weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Hospital
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Affiliated Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Nanjing
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital Of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Jinzhou Central Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tongji hospital of Tongji University
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Institute of Dematology & Blood diseases Hospital
state: Tianjin
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: