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Mantle Cell LymphomaPhase 1/2NCT06106841

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

A Phase 1/2 study testing 400mg of TQB3909 tablets and 600mg of TQB3909 tablets in people with Mantle Cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 28 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
400mg of TQB3909 tablets and 600mg of TQB3909 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
28 sitesChina
Study dates
5 Oct 2023to 16 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 21Show fewer
  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130022

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000

  • Chongqing University Hospital

    Chongqing, Chongqing Municipality, 400030

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

  • Linyi People's Hospital

    Linyi, Shandong, 276000

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

  • The Affiliated Hospital of Xuzhou Medical University

    Nanjing, Jiangsu, 220005

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 215006

  • Shanghai Huashan Hospital

    Shanghai, Shanghai Municipality, 200040

  • Tongji hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300040

  • Institute of Dematology & Blood diseases Hospital

    Tianjin, Tianjin Municipality, 300052

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830001

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

    Wuhan, Hubei, 430050

  • Jinzhou Central Hospital

    Wuxi, Jiangsu, 530031

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

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

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

Being tested
400mg of TQB3909 tablets, 600mg of TQB3909 tablets
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 400mg of TQB3909 tabletsDrug

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

  • 600mg of TQB3909 tabletsDrug

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

Study groups in NCT06106841
Study groupRoleWhat they receive
400mg of TQB3909 tabletsExperimentaltablet, 28 days as a treatment cycle.
Receives: Drug: 400mg of TQB3909 tablets
600mg of TQB3909 tabletsExperimentaltablet, 28 days as a treatment cycle.
Receives: Drug: 600mg of TQB3909 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase II dose (RP2D)

    Recommended phase II dose (RP2D)

    Measured: Baseline up to 48-weeks

Secondary outcomes (4)

  1. 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.

    Measured: Baseline up to 96-weeks

  2. The severity of adverse events (AEs)

    The severity of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

    Measured: Baseline up to 96-weeks

  3. 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.

    Measured: Baseline up to 96-weeks

  4. 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.

    Measured: Baseline up to 96-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start5 Oct 2023
  3. Primary completion16 Oct 2024
  4. Study completion16 Oct 2024

Why it stopped: Study terminated for strategic business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106841
Sponsor's protocol ID
TQB3909-Ib/II-04
Status last verified
Dec 2025
First submitted
24 Oct 2023
Last updated
30 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 400mg of TQB3909 tablets and 600mg of TQB3909 tablets in people with Mantle Cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated for strategic business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase II dose (RP2D) (time frame: Baseline up to 48-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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