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

NCT06106841 | Terminated Phase 1

• 1 other identifier: TQB3909-Ib/II-04
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Recommended phase II dose (RP2D)

  Recommended phase II dose (RP2D)

  Baseline up to 48-weeks

Secondary Outcomes (4)

• The incidence of adverse events (AEs)

  Baseline up to 96-weeks

• The severity of adverse events (AEs)

  Baseline up to 96-weeks

• The severity of severe adverse events (SAEs)

  Baseline up to 96-weeks

• The severity of abnormal laboratory examination indicators

  Baseline up to 96-weeks

Study Arms (2)

400mg of TQB3909 tablets

EXPERIMENTAL

tablet, 28 days as a treatment cycle.

Drug: 400mg of TQB3909 tablets

600mg of TQB3909 tablets

EXPERIMENTAL

tablet, 28 days as a treatment cycle.

Drug: 600mg of TQB3909 tablets

Interventions

400mg of TQB3909 tablets DRUG

TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.

400mg of TQB3909 tablets

600mg of TQB3909 tablets DRUG

TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.

600mg of TQB3909 tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.);
• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (28)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Chongqing University Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China

Location

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

Location

The Affiliated Hospital of Chengde Medical College

Chengde, Hebei, 067000, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430050, China

Location

The Affiliated Hospital of Xuzhou Medical University

Nanjing, Jiangsu, 220005, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The First Affiliated Hospital Of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Jinzhou Central Hospital

Wuxi, Jiangsu, 530031, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130022, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

Location

Linyi People's Hospital

Linyi, Shandong, 276000, China

Location

Shanghai Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Tongji hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300040, China

Location

Institute of Dematology & Blood diseases Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, Xinjiang, 830001, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 215006, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: October 5, 2023
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (28)