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Not yet recruitingNCT07753369Updated Aug 11, 2026

A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

A Phase 3 interventional study of TQB3909 Tablets and Bendamustine Injection in Small Lymphocytic Lymppho and Relapsed/Refractory Chronic Lymphocytic Leukemia, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (part of Sino Biopharmaceutical Limited) · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 108 studies in Leukemia, Lymphocytic, Chronic, B-Cell with a site in China — 39 open to participants now, 60 under way, 19 of them phase 3. Leukemia, Lymphocytic, Chronic, B-Cell · China.

Planned enrollment
36th of 105
128 · median 89
Started
2026
with 6 others
Phase 3
25 of 108
9 open now
Primary completion
2030-12
later than 53 of 59 live
Registered
107th of 108
by date

Among the 108 studies in Leukemia, Lymphocytic, Chronic, B-Cell with a site in China, this one is the 36th largest by planned enrollment of the 105 interventional ones that give a count, is one of 7 that started in 2026, is one of 25 in phase 3, reaches primary completion later than 53 of the 59 other live ones, and was the 107th registered.

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Open to participants now

39 of the 108 studies in Leukemia, Lymphocytic, Chronic, B-Cell with a site in China are open now. Recruiting first, the newest first:

34 more — sign in →

All 39 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

To Evaluate the Efficacy and Safety of TQB3909 Tablets versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

03

Conditions studied

  • Small Lymphocytic Lymppho
  • Relapsed/Refractory Chronic Lymphocytic Leukemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The subject voluntarily agrees to participate in this study, signs the form, and is expected to be compliant.
  2. Age: ≥18 years; PS score: 0-2; expected survival >3 months.
  3. Subject population:

    1. Patients with a confirmed diagnosis of CLL/SLL according to the diagnostic criteria of the revised 2018 iwCLL guidelines;
    2. Meet at least one indication for treatment of CLL/SLL according to the revised 2018 iwCLL guidelines;
    3. Have developed treatment intolerance during or after immunochemotherapy and BTK inhibitor therapy, or have failed to achieve PR or better response after adequate treatment, or have experienced disease progression. For patients assessed by the investigator as unfit for immunochemotherapy, they must have developed treatment intolerance during BTK inhibitor therapy, failed to achieve PR or better response after adequate treatment, or experienced disease progression after adequate treatment.
  4. Adequate major organ function.
  5. SLL patients must have on CT/MRI.
  6. Female subjects of must agree to use (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the last dose; serum pregnancy test must be negative within 7 days prior to enrollment, and must not be breastfeeding. Male subjects must agree to use contraception during the study and for 6 months after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. Comorbidities and Medical History:

    1. History of or concurrent other within 3 years prior to the first dose. The following two conditions are allowed: other malignancies treated with surgery alone and achieving continuous disease-free survival (DFS) of 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading lamina propria)];
    2. History of Richter's transformation or prolymphocytic leukemia (PLL);
    3. Known lymphoma/leukemia involvement of the central nervous system (CNS);
    4. Prior hematopoietic stem cell transplantation;
    5. Autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
    6. Multiple factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, bowel obstruction, etc.);
    7. Active or uncontrolled cytopenia despite low-dose therapy (equivalent to prednisone 20 mg), including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP);
    8. Toxicity from any prior treatment that has not recovered to ≤ Grade 1 per , excluding alopecia, , and count;
    9. Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment;
    10. Severe arterial/venous thromboembolic events within 3 months prior to the first dose, such as cerebrovascular accidents (including , intracranial hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.;
    11. History of psychoactive substance abuse that cannot be discontinued, or psychiatric disorders;
    12. Subjects with any severe and/or uncontrolled diseases, including:

    Myocardial ischemia or myocardial infarction ≥ Grade 2, arrhythmia ( >450 ms for males, QTcF >470 ms for females), and ≥ Grade 2 congestive heart failure ( [NYHA] classification), or (LVEF) \<50% by echocardiography within 6 months prior to the first dose; Active infection (≥ Grade 2 infection per CTCAE); Active hepatitis*; : HBV DNA ≥ lower limit of detection; : HCV antibody positive and HCV viral titer > lower limit of detection; History of immunodeficiency, including positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; Epilepsy requiring treatment;

  2. Tumor-Related Symptoms and Treatment:

    1. Chemotherapy, monoclonal antibody therapy, or radiotherapy within 4 weeks prior to the first dose; or CAR-T therapy within 12 weeks prior to the first dose; other small-molecule anti-tumor therapies within 5 half-lives (calculated from the end date of the last treatment);
    2. Corticosteroids administered for anti-tumor purposes; short-term (≤7 days) systemic corticosteroid therapy (≤20 mg prednisone equivalent) to control lymphoma-related symptoms or BTKi withdrawal symptoms prior to enrollment is permitted, but tapering to discontinuation within 5 days after study start is required;
    3. Prior treatment with BCL-2 inhibitors;
    4. Retreatment with bendamustine is allowed if the prior response to bendamustine lasted >24 months;
  3. Study Treatment-Related: Vaccination within 4 weeks prior to the first dose, or planned vaccination during the study;
  4. Participation in other anti-tumor drug clinical trials within 4 weeks prior to the first dose; for small-molecule targeted drugs with defined targets such as BTK inhibitors, calculated as 5 half-lives;
  5. Subjects with concomitant diseases that seriously endanger subject safety or affect study completion, or subjects considered unsuitable for enrollment for other reasons, as judged by the investigator;
  6. Allergy to both allopurinol and benzbromarone.
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    TQB3909 Tablets

    The drug was administered every day for 28 consecutive days in a treatment cycle

    Drug: TQB3909 Tablets

  • Active comparator
    BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection

    BR Regimen Bendamustine Hydrochloride for Injection: 70 mg/m², intravenous (IV) administration on Days 1-2 of each cycle. IV infusion over 60-120 minutes. Rituximab Injection: Intravenous administration at 375 mg/m² on Day 1 of Cycle 1, and at 500 mg/m² on Day 1 of Cycles 2-6. R2 Regimen Lenalidomide Capsules: 10 mg/day, orally starting from Day 9 of Cycle 1. Each cycle consists of 28 days. Rituximab Injection: 375 mg/m², intravenous (IV) administration on Days 1, 8, 15, and 22 of Cycle 1, followed by 375 mg/m² on Day 1 of Cycles 3-12. Each cycle consists of 28 days.

    Drug: Bendamustine Injection · Drug: Rituximab injection · Drug: Lenalidomide Capsules

Interventions

  • TQB3909 Tablets is a BCL-2 inhibitor.

  • Bendamustine A bifunctional alkylating agent with dual characteristics of both an alkylating agent and a purine analogue. It exerts its anti-tumor effects by forming DNA cross-links and inducing single-strand and double-strand DNA breaks, thereby blocking DNA replication and transcription in tumor cells and ultimately leading to apoptosis. It is not fully cross-resistant with other alkylating agents.

  • Rituximab A chimeric anti-CD20 monoclonal antibody. It targets the CD20 antigen on the surface of B lymphocytes and kills cells through three mechanisms: antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. It primarily depletes B cells (including both normal and malignant B cells) and is effective against B-cell-derived lymphomas/leukemias such as CLL/SLL.

  • Lenalidomide An immunomodulatory drug (IMiD) that binds to the E3 ubiquitin ligase substrate recognition protein cereblon, promoting the ubiquitination and degradation of transcription factors Ikaros and Aiolos. Its downstream effects include: enhancing the anti-tumor activity of NK cells and T cells, directly inducing tumor cell apoptosis, inhibiting tumor angiogenesis, and modulating the tumor microenvironment.

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS) evaluated by an independent review committee (IRC)

    Progression free survival (PFS) evaluated by an independent review committee (IRC)

    Time frame: Up to 4 years

Secondary outcomes

  1. Overall Survival (OS)

    the time interval from the start of first study treatment to death due to any cause.

    Time frame: Up to 4 years

  2. Progression free survival (PFS) evaluated by researchers

    The time from randomization to researcher evaluation of disease progression or death from any cause (whichever occurs first) is determined according to the 2014 Lugano criteria and LYRIC.

    Time frame: Up to 4 years

  3. Objective response rate (ORR)

    The percentage of complete (CR) or partial response (PR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively

    Time frame: Up to 4 years

  4. Duration of Response (DOR) per Independent Review Committee (IRC) and investigator assessment

    defined as the time from the date of first documented Complete Response (CR) or Partial Response (PR) to the date of first documented disease progression, start of new anti-tumor therapy, or death.

    Time frame: Up to 4 years

07

Study locations

2 sites
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2030, 52 months later.

Of 57 industry-sponsored phase 3 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 73. This study's planned 52 months is close to that.

Counting every sponsor, half of 83 studies reached it within 59 months; a quarter within 43 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 7, 2026
StartEst.
Aug 2026
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07753369
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Aug 2026 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 11, 2026

Study contacts

Jian Yong Li, doctor
Contact
lijianyonglm@126.com
13951877733
Ke Shu Zhou, doctor
Contact
dr_zkshu23810@163.com
13674902391

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bcl-2 Inhibitor TQB3909

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