TQB3909 tablets for patients with relapsed or refractory mantle cell lymphoma

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

This study is testing if TQB3909 tablets can help adults with relapsed or refractory mantle cell lymphoma feel better and manage their disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor, chemotherapy, Immunotherapy
• Locations: 28 sites (Beijing, Beijing and 27 other locations)
• Trial ID: NCT06106841 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of TQB3909 monotherapy in adults diagnosed with relapsed or refractory mantle cell lymphoma (MCL). Participants will receive either 400mg or 600mg doses of TQB3909 tablets. The study aims to determine how well the drug works in managing the disease and its associated side effects. Eligible patients must have measurable lesions and a performance status indicating they can tolerate treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed relapsed or refractory mantle cell lymphoma and measurable disease.

Not a fit: Patients with other types of lymphoma or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat mantle cell lymphoma.

How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting relapsed or refractory lymphomas, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing and 27 other locations

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

Study contacts

• Study coordinator: Lugui Qiu, Doctor

Conditions Mantle Cell Lymphoma