Experimental MCL drug trial halted early – what we know
NCT ID NCT06106841
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called TQB3909 in 19 people with mantle cell lymphoma that had returned or stopped responding to treatment. The goal was to find a safe dose and check for side effects. However, the study was terminated early, so we have limited information about how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQB3909 tablets (a BCL-2 inhibitor)
- What this could lead to
- If successful, this could provide a new treatment option for people with mantle cell lymphoma that has stopped responding to other therapies.
- What could go wrong
- The trial was terminated early with only 19 participants, so results are very limited. It is unclear if TQB3909 is safe or effective, and it may not work for most patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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19 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
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Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
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Chongqing University Hospital
Chongqing, Chongqing Municipality, 400030, China
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Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
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Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
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Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
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Institute of Dematology & Blood diseases Hospital
Tianjin, Tianjin Municipality, 300052, China
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Jilin Cancer Hospital
Changchun, Jilin, 130012, China
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Jinzhou Central Hospital
Wuxi, Jiangsu, 530031, China
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Linyi People's Hospital
Linyi, Shandong, 276000, China
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
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The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000, China
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The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
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The Affiliated Hospital of Xuzhou Medical University
Nanjing, Jiangsu, 220005, China
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The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006, China
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The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 215006, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
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The First Hospital of Jilin University
Changchun, Jilin, 130022, China
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The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
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The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300040, China
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430050, China
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Tongji hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
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Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- Can a single injection reprogram immune cells to fight cancer?