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Relapsed or Refractory Diffuse Large B-cell LymphomaPhase 2NCT06074107

Study of BEBT-908 in the Relapsed or Refractory Diffuse Large B-cell Lymphoma Subjects

A Phase 2 study testing BEBT-908 for injection in people with Relapsed or Refractory Diffuse Large B-cell Lymphoma, run by BeBetter Med Inc at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open,single-arm,multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: phase Ⅱa and phase Ⅱb. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BEBT-908 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteChina
Study dates
12 Jun 2020to 11 Mar 2025
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is willing to sign the informed consent form (ICF) after a comprehensive understanding.
  • Age ≥ 18 years and ≤ 75 years, male or female.
  • Diffuse large B-cell lymphoma was confirmed by central pathological examination and tissue biopsy.(Note 1)
  • With measurable lesions.(Note 2)
  • Refractory or relapse after at least two kinds of systematic treatment. (Note 3)
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
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  • Life expectancy > 12 weeks.
  • The level of organ function must meet the following requirements:
  • Peripheral blood:
  • Absolute neutrophil count (ANC) ≥ 1000 /μL.
  • Hemoglobin (HGB) ≥ 8g/dL.
  • Platelet count (PLT) ≥ 1000000 /μL.
  • Liver function:
  • Serum total bilirubin ≤ 1.5 × Upper limit of normal value （ULN） (for patients with Gilbert syndrome, total bilirubin < 3.0 × ULN and direct bilirubin within the normal range).
  • Serum creatinine < 1.5 × ULN.
  • Alanine aminotransferase （ALT）, aspartate aminotransferase （AST） or alkaline phosphatase （ALP ）≤ 2.5 × ULN (≤ 5 × ULN when liver involvement is involved).
  • Note 1: Patients with recurrence for more than one year need to undergo another tissue biopsy to confirm the pathological diagnosis.
  • Note 2: the criteria for measurable lesions are as follows: the longest diameter of lymph node lesions is more than 15 mm under enhanced Computed Tomography （ （CT ）or Magnetic Resonance Imaging (MRI), the longest diameter of extranodal lesions is more than 10 mm, or the longest diameter of extranodal lesions is ≥ 10 mm under Positron Emission Tomography/Computed Tomography (PET/CT). Bone marrow aspiration cytology and / or biopsy may be performed when evaluating the curative effect.
  • Note 3: Relapsed / refractory diffuse large B lymphoma is defined in this regimen as: 1) relapsed more than 6 months after the end of second-line treatment; 2) those who relapse within 6 months after the end of second-line treatment and those who do not reach partial response (PR) for 2 or more cycles of second-line treatment can be selected as refractory patients without the requirement of treatment cycle. 3) after sequential hematopoietic stem cell transplantation with second-line therapy, recurrence within 6 months can be included in the group. Previous treatment should include anti-CD20 monoclonal antibody and cytotoxic drug therapy; anti-CD20 monoclonal antibody consolidation therapy or induction therapy cannot be counted as a single line of treatment; previous stem cell transplantation is allowed; autologous stem cell transplantation or allogeneic stem cell transplantation alone does not count as first-line therapy, induction, consolidation, stem cell collection, pretreatment regimen and transplantation ±maintenance therapy belong to the same line of treatment.

Who cannot join

  • It is known to be severely allergic to research drugs or any of their excipients.
  • Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded:
  • Men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial. Unless follow-up studies confirm reproductive safety.
  • pregnant or lactating women.
  • Primary central nervous system lymphoma or lymphoma invading the central nervous system.
  • Previous transformation of chronic lymphoma (such as Richter syndrome, pre-lymphocytic leukemia, etc.).
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  • There are other active malignant tumors that may interfere with this study.
  • Pre-trial treatment:
  • Have received any persistent or intermittent treatment such as Phosphoinositide 3-kinase (PI3K) inhibitors, Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors or other small molecule targeted drugs within 2 weeks before entering the group.
  • Autologous hematopoietic stem cell transplantation within 3 months before enrollment.
  • Received radiotherapy that affected the efficacy evaluation of this study or local supportive radiotherapy that affected the bone marrow function of the subjects within 3 months before enrollment.
  • Bone marrow inhibitory chemotherapy or biotherapy was performed within 3 weeks before enrollment.
  • Major surgery other than tumor biopsy was performed within 4 weeks before enrollment, or the side effects of the operation were not stable.
  • Received any hematopoietic colony-stimulating factor therapy (such as granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF)) or thrombopoietin （TPO） within 2 weeks before enrollment. (Note 1)
  • received prednisone daily > 10mg (or other dose-effective corticosteroids) within 7 days before enrollment. (Note 2)
  • Chimeric antigen receptor T cell immunotherapy (CAR-T therapy) was performed within 3 months before enrollment.
  • After the previous treatment (chemotherapy or biotherapy), there were persistent toxicity of grade 2 or above (Common Terminology Criteria for Adverse Events V5.0 （CTCAE V5.0 ）), which was not stable at the time of admission (except hair loss).
  • There are severe clinical infections in active stage with grade 2 or above (CTCAE V5.0).
  • Concomitant disease:
  • Diabetes with poor blood glucose control (random blood glucose ≥ 11.1mmol/L or Hemoglobin A1C (HbA1c ）≥ 8.5% after hypoglycemic treatment).
  • Severe lung disease (CTCAE V5.0, III-IV).
  • Severe heart disease. (Note 3)
  • With significant renal or liver dysfunction.
  • Poorly controlled active hepatitis B or C diseases;(Note 4)
  • known to be HIV positive.
  • A history of mental illness, family history of mental illness or emotional disorder is determined by a researcher or psychiatrist. (Note 5)
  • Combined use of drugs that cause prolonged QT interval or twisted ventricular tachycardia.
  • The patients were treated with cytochrome P450 (CYP) 3A4 isozyme inhibitors or strong induction drugs within 4 weeks before enrollment. (Note 6)
  • Participated in other clinical trials and used research drugs within 4 weeks before joining the group.
  • The researchers judged any unstable or likely to endanger the safety of subjects and their compliance with the study.
  • The researchers believe that it is not suitable for subjects who are treated with this regimen.
  • Note 1: Subjects who began to receive erythropoietin or diplotene within 2 weeks before enrollment can be enrolled in the group.
  • Note 2: If used to treat diseases other than lymphoma, such as rheumatoid arthritis, rheumatic polymyalgia, adrenocortical dysfunction or asthma, subjects can receive a maximum daily dose of 10mg with a stable dose of prednisone (or other equivalent glucocorticoid).
  • Note 3: Including any of the following: left ventricular ejection fraction (LVEF) < 50% found by cardiac radionuclide scanning (Multigated Radionuclide Angiography （MUGA）) or echocardiography (ECHO) corrected QT value (QTcF interval) male > 450ms, female > 470ms (QTcF formula); unstable angina pectoris; symptomatic pericarditis; abnormal recording of the left ventricular wall in areas with persistent elevated myocardial enzymes or persistent LVEF function measurements in the past 6 months of myocardial infarction.
  • History of congestive heart failure (New York College of Cardiology III-IV Appendix 3), cardiomyopathy record.
  • Note 4: The following active infections with clinical significance, including hepatitis B (HBV) and hepatitis C (HCV). Active hepatitis B is defined as hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive, and HBV DNA ≥ 2000 IU/ml (equivalent to 10^4 copies / ml), (hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive, HBV DNA < 2000 IU/ml, according to infectious disease control requirements, subjects should continue to take entecavir until one year after the end of the study). Active hepatitis C is defined as: HCV RNA is higher than the upper limit of detection.
  • Note 5: including medical records with history of depressive episodes, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, suicidal attempts or suicidal ideations, or thoughts of "being at immediate risk of harming others", anxiety level 3 or above, etc.
  • Note 6: moderate or weak CYP3A inhibitors are allowed in combination; a list of common CYP3A4 inhibitors or inducers is shown in Appendix 5 of the study scheme.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: An Open, Multicenter Phase II Study of the Efficacy and Safety of BEBT-908 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

This is an open,single-arm,multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: phase Ⅱa and phase Ⅱb. Phase Ⅱa is an exploratory study, which mainly explores the safe and effective dose and the relationship between gene and protein markers and drug sensitivity. The main purpose of the phase Ⅱb study was to evaluate the Objective response rate of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma, and the secondary study was to evaluate the disease control rate, progression-free survival, time to response, duration of response, overall survival and safety tolerance of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The relationship between the biomarkers of BEBT-908 for injection and the efficacy and safety was evaluated.

Read the detailed description

This is an open, single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: Ⅱa and Ⅱb, stage Ⅱa is an exploratory study, which mainly explores the safe and effective dose, 30 cases are planned to be included in the group, stage Ⅱb mainly evaluates the efficacy and safety of BEBT-908 for injection, according to the preliminary overall efficacy analysis of stage Ⅱa, the sample size of stage Ⅱb is about 90 cases.

In phase Ⅱa and Ⅱb study, the initial dose was 22.5mg/m2, intravenous drip, 21 days as a cycle and 6 cycles as the total treatment cycle. The drugs were given on the 1st, 3rd, 5th, 8th, 10th and 12th day of each cycle. The study process of each subject included three periods: screening period, treatment period and follow-up period after treatment. During the treatment period, all safety items were examined before administration on the first day of each cycle, and the tumor was evaluated every 2 cycles. After the termination of treatment, the subjects will enter the follow-up period. Receive curative effect follow-up every 6 weeks (to tumor progression or other anti-tumor therapy) and survival follow-up every 3 months.

Being tested
BEBT-908 for injection
Keywords
BEBT-908, safety, efficacy
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • BEBT-908 for injectionDrug

    Also called CUDC-908

    The initial dose is 22.5mg/m2, intravenous drip, on the 1st, 3rd, 5th, 8th, 10th and 12th day of each cycle，21 days as a cycle, 6 cycles as the total treatment cycle.

Study groups in NCT06074107
Study groupRoleWhat they receive
BEBT-908 for injectionExperimentalBEBT-908 for injection, dosage form: injection, specification: 25mg, administration method: the initial dose was 22.5mg/m2, intravenous drip, 3 times a week, 21 days as a cycle, 6 cycles as the total treatment cycle.
Receives: Drug: BEBT-908 for injection

What is being measured

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

  1. ORR

    Objective response rate

    Measured: 6 weeks， assessed up to 24 months.

Secondary outcomes (6)

  1. DCR

    Disease Control Rate

    Measured: Every 6 weeks， assessed up to 24 months.

  2. PFS

    Progress Free Survival

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  3. TTR

    Time to Response

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  4. DOR

    Duration of Response

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  5. OS

    Overall Survival

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

  6. AE

    Adverse Event

    Measured: From the first administration of the study drug to 30 days after the last administration of the study drug.

Timeline

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

  1. First posted10 Oct 2023
  2. Study start12 Jun 2020
  3. Primary completion17 Jul 2023
  4. Study completion11 Mar 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074107
Sponsor's protocol ID
GBMT-908-P02
Status last verified
Aug 2026
First submitted
27 Sep 2023
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BEBT-908 for injection in people with Relapsed or Refractory Diffuse Large B-cell Lymphoma, run by BeBetter Med Inc at 1 site 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 19 inclusion and 38 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: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ORR (time frame: 6 weeks， assessed up to 24 months.). 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 NCT06074107.

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 18 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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