Relapsed/Refractory Diffuse Large B-Cell LymphomaPhase 1NCT06164327
Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 1 study testing BEBT-908 for Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, run by BeBetter Med Inc at 1 site in China.
Trial summary
This is a multicenter, open Phase Ib clinical study to evaluate the safety,efficacy and pharmacokinetics of BEBT-908 combined with Rituximab (R) or combined with Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) or combined with Rituximab-Ifosfamide-Carboplatin-Etoposide (R-ICE) in the treatment of Relapsed/Refractory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- What is being tested?
- BEBT-908 for Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 5 Nov 2025
- Phase
- Phase 1
- 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 comprehensive understanding;
- Age ≥18 years and ≤75 years, both male and female;
- The pathology was confirmed as diffuse large B-cell lymphoma according to the 2016 World Health Organization classification definition;
- Evaluation by Positron Emission Computed Tomography (PET-CT) or Computed Tomography (CT) or Magnetic resonance imaging (MRI) using Lugano 2014 standard, with measurable lesion injection;
- Must have recurrent or refractory diffuse large B-cell lymphoma after at least 1 systemic therapy, and at least 1 systemic therapy included CD20 antibody;
- Eastern Cooperative Oncology Group (ECOG) scores 0-2 points;
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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) ≥100,000/μL;
- Liver function:
- Serum total bilirubin ≤1.5×ULN (for patients with Gilbert syndrome, total bilirubin <3.0×ULN and Direct bilirubin within normal range);
- Serum creatinine <1.5×ULN;
- ALT, AST or ALP≤2.5×ULN (≤5×ULN when liver involvement occurs).
Who cannot join
- Known severe allergy to the investigational drug or any of its excipients;
- Due to the possibility of genotoxicity, mutagenicity and teratogenicity of the investigational drug, the following subjects should be excluded:
- Men and women who have not had sperm or egg preservation in vitro before the trial and plan to have another child within 5 years unless subsequent studies confirm reproductive safety;
- Pregnant or lactating women;
- Primary central nervous system lymphoma or lymphoma invading the central nervous system;
- Previous chronic lymphoma transformation (such as Richter syndrome, prelymphocytic leukemia, etc.);
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- There are other active malignant tumors requiring treatment that may interfere with the study;
- Pre-trial treatment:
- Received any persistent or intermittent PI3K inhibitor and HDAC inhibitor prior to enrollment or received other small-molecule targeted drug therapy within 2 weeks;
- Received BEBT-908 (not allowed to be in all cohorts) or R-ICE (not allowed to be in cohorts with BEBT-908+R-ICE) or R-GemOx (not allowed to be in cohorts with BEBT-908+R-GemOx) prior to enrollment;
- Autologous hematopoietic stem cell transplantation within 3 months before enrollment;
- Received radiotherapy that affected the evaluation of the efficacy of the study or local supportive radiotherapy that affected the bone marrow function of the subjects within 3 months before enrollment;
- Received myelosuppressive chemotherapy or biotherapy within 3 weeks prior to enrollment;
- Used Chinese medicines and proprietary Chinese medicines with anti-tumor effects within 2 weeks before enrollment;
- Undergone major surgery other than tumor biopsy within 4 weeks prior to enrollment, or the side effects of surgery had not stabilized;
- Any hematopoietic colony-stimulating factor (e.g., granulocyte colony-stimulating factor G-CSF, granulocyte macrophage colony-stimulating factor GM-CSF) or thrombopoietin TPO were treated within 2 weeks prior to enrollment；
- Received prednisone >10mg daily (or another equivalent dose of glucocorticoid) within 7 days prior to enrollment;
- Received chimeric antigen receptor T cell immunotherapy (CAR-T therapy) within 3 months before enrollment;
- Persistent grade 2 or higher [Common Terminology Criteria for Adverse Events V5.0 standard (CTCAE V5.0 standard)] toxicity after previous treatment (chemotherapy or biotherapy), not stable at enrollment (except alopecia);
- Active clinical severe infection of grade 2 or above (CTCAE V5.0 standard);
- Complicated diseases:
- diabetes mellitus with poor glycemic control (random glycemic value ≥11.1mmol/L after hypoglycemic treatment, or glycosylated hemoglobin（HbA1c）≥ 8.5%);
- severe lung disease (CTCAE V5.0 grade III-IV);
- Serious heart disease;
- have significant kidney or liver dysfunction;
- Poorly controlled active diseases such as hepatitis B or C;
- Known human immunodeficiency virus (HIV) positive;
- A history of mental illness, family history of mental illness, or mood disorder, as judged by the investigator or psychologist, and the researcher judged that they were not suitable for inclusion;
- Combination of anticoagulation and antiplatelet therapy is required during the study period;
- uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg);
- Serious physical disease combined with the risk of major bleeding or a history of major bleeding;
- Combined with use of drugs that cause QT interval prolongation or torsional ventricular tachycardia;
- Receiving cytochrome P450 (CYP) 3A4 isozyme suppressant or strongly induced drug therapy during the first 4 weeks of enrollment；
- Participated in other clinical trials and used investigational drugs within 4 weeks before enrollment;
- Any condition that the investigator determines to be unstable or likely to compromise the subject's safety and compliance with the study;
- Subjects deemed unsuitable for treatment with this protocol by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Xizhen Hu, Bachelor, +86-15802510972, xhu@bebettermed.com
About this study
Official title: A Multicenter, Open Phase Ib Study of the Safety and Efficacy of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This is a multicenter, open Phase Ib clinical study to evaluate the safety,efficacy and pharmacokinetics of BEBT-908 combined with Rituximab (R) or combined with Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) or combined with Rituximab-Ifosfamide-Carboplatin-Etoposide (R-ICE) in the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
Read the detailed description
This study sets up three cohorts, including BEBT-908 combined with R, BEBT-908 combined with R-ICE, and BEBT-908 combined with R-GemOx. The researchers decide whether to terminate the cohort study according to the safety and tolerability results of each cohort during the first cycle of medication. If the participants in the above three cohorts are unable to receive the treatment during the first cycle of medication, two alternative cohort studies will be conducted. Namely, BEBT-908 monotherapy (alternative cohort 1), adjustment of BEBT-908 combined with GemOx administration regimen (alternative cohort 2).
The study process for each participant includes a screening period, a treatment period, and a post-treatment follow-up period. During treatment, participants are evaluated for tumors every 6 weeks, follow up after termination of treatment with efficacy follow-up every 6 weeks for those without disease progression and survival follow-up every 3 months until disease progression (PD), death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurred first).
- Being tested
- BEBT-908 for Injection, Rituximab Injection, Gemcitabine Hydrochloride for Injection, Oxaliplatin Injection, Etoposide Injection
- Keywords
- BEBT-908, Drug combination, Safety, Efficacy
- Medical subject headings
- 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
BEBT-908 for Injection,dosage of administration:15mg/m^2 or 22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle,and 21 days as a cycle.
Rituximab InjectionDrug
Also called IDEC-C2B8
Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle, and 21 days as a cycle.
Gemcitabine Hydrochloride for InjectionDrug
Also called NSC 613327
Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
Oxaliplatin InjectionDrug
Also called NSC 266046
Oxaliplatin Injection，dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
Etoposide InjectionDrug
Also called VP-16213
Etoposide Injection,dosage of administration:100mg/m^2，frequency and duration of administration:on the 1st,2nd and 3rd days of each cycle,and 21 days as a cycle.
Ifosfamide for InjectionDrug
Also called NSC109724
Ifosfamide for Injection,dosage of administration:5000mg/m^2,24 hours of continuous intravenous drip，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
Carboplatin InjectionDrug
Also called NSC 241240
Carboplatin Injection，dosage of administration:based on AUC=5, single dose ≤800 mg，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| BEBT-908 combined with R | Experimental | BEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle.
Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle, and 21 days as a cycle. Receives: Drug: BEBT-908 for Injection; Drug: Rituximab Injection |
| BEBT-908 combined with R-GemOx | Experimental | BEBT-908 for Injection,dosage of administration:15mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle.
Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 1st to 6th cycles, and 21 days as a cycle.
Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle.
Oxaliplatin Injection,dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Receives: Drug: BEBT-908 for Injection; Drug: Rituximab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Oxaliplatin Injection |
| BEBT-908 combined with R-ICE | Experimental | BEBT-908 for Injection,dosage of administration:15mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle.
Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 1st to 6th cycles, and 21 days as a cycle.
Etoposide Injection,dosage of administration:100mg/m^2，frequency and duration of administration:on the 1st,2nd and 3rd days of each cycle in the 1st to 6th cycles,and 21 days as a cycle.
Ifosfamide for Injection,dosage of administration:5000mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle.
Carboplatin Injection，dosage of administration:based on AUC=5, single dose ≤800 mg，frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Receives: Drug: BEBT-908 for Injection; Drug: Rituximab Injection; Drug: Etoposide Injection; Drug: Ifosfamide for Injection; Drug: Carboplatin Injection |
| BEBE-908 monotherapy (alternative cohort 1) | Experimental | BEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. Receives: Drug: BEBT-908 for Injection |
| BEBT-908 combined with R-GemOx（alternative cohort 2） | Experimental | BEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 2nd cycles,and 21 days as a cycle.
Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle.
Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle.
Oxaliplatin Injection,dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle. Receives: Drug: BEBT-908 for Injection; Drug: Rituximab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Oxaliplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: Every 6 weeks，assessed up to 24 months.
AE
Adverse event
Measured: From the first administration of the study drug to 28 days after the last administration of the study drug
Secondary outcomes (12)
ORR-EoT
Objective response rate after completion of treatment
Measured: Every 6 weeks，assessed up to 6 treatment cycles (each cycle is 21 days).
PFS
Progression-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
OS
Overall Survival
Measured: From date of administration until date of death from any cause, assessed up to 24 months.
CBR
Clinical benefit rate
Measured: Every 6 weeks，assessed up to 24 months.
DOR
Duration of Response
Measured: Every 6 weeks，assessed up to 24 months.
DCR
Disease Control Rate
Measured: Every 6 weeks，assessed up to 24 months.
TTR
Treatment response time
Measured: Every 6 weeks，assessed up to 24 months.
Tmax
Time of peak Plasma Concentration
Measured: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
Cmax
Peak Plasma Concentration
Measured: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
t1/2
Half-life of plasma drug concentrations
Measured: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
AUC0-t
Area under the plasma concentration time curve from 0 hour to last time of quantifiable concentration after administration
Measured: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
CL
apparent plasma clearance
Measured: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Dec 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion5 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study sets up three cohorts of BEBT-908 combined with different drugs.The researchers decide whether to terminate the cohort study according to the safety and tolerability results of each cohort during the first cycle of medication. If the participants in the above three cohorts are unable to receive the treatment during the first cycle of medication, two alternative cohort studies will be conducted.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeBetter Med Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Phd, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164327
- Sponsor's protocol ID
- GBMT-908-P06
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Phase Ib Study of the Safety and Efficacy of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06164327
- Acronym / sponsor ID
- GBMT-908-P06
- Keywords
- BEBT-908, Drug combination, Safety, Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- BeBetter Med IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 5 Nov 2025 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open Phase Ib clinical study to evaluate the safety,efficacy and pharmacokinetics of BEBT-908 combined with Rituximab (R) or combined with Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) or combined with Rituximab-Ifosfamide-Carboplatin-Etoposide (R-ICE) in the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
Detailed description
This study sets up three cohorts, including BEBT-908 combined with R, BEBT-908 combined with R-ICE, and BEBT-908 combined with R-GemOx. The researchers decide whether to terminate the cohort study according to the safety and tolerability results of each cohort during the first cycle of medication. If the participants in the above three cohorts are unable to receive the treatment during the first cycle of medication, two alternative cohort studies will be conducted. Namely, BEBT-908 monotherapy (alternative cohort 1), adjustment of BEBT-908 combined with GemOx administration regimen (alternative cohort 2).
The study process for each participant includes a screening period, a treatment period, and a post-treatment follow-up period. During treatment, participants are evaluated for tumors every 6 weeks, follow up after termination of treatment with efficacy follow-up every 6 weeks for those without disease progression and survival follow-up every 3 months until disease progression (PD), death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurred first).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study sets up three cohorts of BEBT-908 combined with different drugs.The researchers decide whether to terminate the cohort study according to the safety and tolerability results of each cohort during the first cycle of medication. If the participants in the above three cohorts are unable to receive the treatment during the first cycle of medication, two alternative cohort studies will be conducted.
| Arm | Type | Receives |
|---|---|---|
| BEBT-908 combined with R | Experimental | Drug: BEBT-908 for Injection, Drug: Rituximab InjectionBEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle, and 21 days as a cycle. |
| BEBT-908 combined with R-GemOx | Experimental | Drug: BEBT-908 for Injection, Drug: Rituximab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Oxaliplatin InjectionBEBT-908 for Injection,dosage of administration:15mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Oxaliplatin Injection,dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. |
| BEBT-908 combined with R-ICE | Experimental | Drug: BEBT-908 for Injection, Drug: Rituximab Injection, Drug: Etoposide Injection, Drug: Ifosfamide for Injection, Drug: Carboplatin InjectionBEBT-908 for Injection,dosage of administration:15mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Etoposide Injection,dosage of administration:100mg/m^2，frequency and duration of administration:on the 1st,2nd and 3rd days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. Ifosfamide for Injection,dosage of administration:5000mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. Carboplatin Injection，dosage of administration:based on AUC=5, single dose ≤800 mg，frequency and duration of administration:on the 2nd day of each cycle in the 1st to 6th cycles, and 21 days as a cycle. |
| BEBE-908 monotherapy (alternative cohort 1) | Experimental | Drug: BEBT-908 for InjectionBEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 6th cycles,and 21 days as a cycle. |
| BEBT-908 combined with R-GemOx（alternative cohort 2） | Experimental | Drug: BEBT-908 for Injection, Drug: Rituximab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Oxaliplatin InjectionBEBT-908 for Injection,dosage of administration:22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle in the 1st to 2nd cycles,and 21 days as a cycle. Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle. Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle. Oxaliplatin Injection,dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle in the 3rd to 6th cycles, and 21 days as a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subject is willing to sign the informed consent form (ICF) after comprehensive understanding;
- Age ≥18 years and ≤75 years, both male and female;
- The pathology was confirmed as diffuse large B-cell lymphoma according to the 2016 World Health Organization classification definition;
- Evaluation by Positron Emission Computed Tomography (PET-CT) or Computed Tomography (CT) or Magnetic resonance imaging (MRI) using Lugano 2014 standard, with measurable lesion injection;
- Must have recurrent or refractory diffuse large B-cell lymphoma after at least 1 systemic therapy, and at least 1 systemic therapy included CD20 antibody;
Key exclusion criteria (36 listed)
- Known severe allergy to the investigational drug or any of its excipients;
- Due to the possibility of genotoxicity, mutagenicity and teratogenicity of the investigational drug, the following subjects should be excluded:
- Primary central nervous system lymphoma or lymphoma invading the central nervous system;
- Previous chronic lymphoma transformation (such as Richter syndrome, prelymphocytic leukemia, etc.);
- There are other active malignant tumors requiring treatment that may interfere with the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEBT-908 for InjectionAlso: CUDC-908BEBT-908 for Injection,dosage of administration:15mg/m^2 or 22.5mg/m^2，frequency and duration of administration:on the 1st,3rd,5th,8th,10th and 12th days of each cycle,and 21 days as a cycle. | Drug | BEBE-908 monotherapy (alternative cohort 1), BEBT-908 combined with R, BEBT-908 combined with R-GemOx, BEBT-908 combined with R-GemOx（alternative cohort 2）, BEBT-908 combined with R-ICE |
| Rituximab InjectionAlso: IDEC-C2B8Rituximab Injection,dosage of administration:375 mg/m^2,frequency and duration of administration:on the 1st day of each cycle, and 21 days as a cycle. | Drug | BEBT-908 combined with R, BEBT-908 combined with R-GemOx, BEBT-908 combined with R-GemOx（alternative cohort 2）, BEBT-908 combined with R-ICE |
| Gemcitabine Hydrochloride for InjectionAlso: NSC 613327Gemcitabine Hydrochloride for Injection，dosage of administration:1g/m^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle. | Drug | BEBT-908 combined with R-GemOx, BEBT-908 combined with R-GemOx（alternative cohort 2） |
| Oxaliplatin InjectionAlso: NSC 266046Oxaliplatin Injection，dosage of administration:100mg/m^2,frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle. | Drug | BEBT-908 combined with R-GemOx, BEBT-908 combined with R-GemOx（alternative cohort 2） |
| Etoposide InjectionAlso: VP-16213Etoposide Injection,dosage of administration:100mg/m^2，frequency and duration of administration:on the 1st,2nd and 3rd days of each cycle,and 21 days as a cycle. | Drug | BEBT-908 combined with R-ICE |
| Ifosfamide for InjectionAlso: NSC109724Ifosfamide for Injection,dosage of administration:5000mg/m^2,24 hours of continuous intravenous drip，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle. | Drug | BEBT-908 combined with R-ICE |
| Carboplatin InjectionAlso: NSC 241240Carboplatin Injection，dosage of administration:based on AUC=5, single dose ≤800 mg，frequency and duration of administration:on the 2nd day of each cycle, and 21 days as a cycle. | Drug | BEBT-908 combined with R-ICE |
Primary outcome
ORR
Time frame: Every 6 weeks，assessed up to 24 months.
Objective response rate
AE
Time frame: From the first administration of the study drug to 28 days after the last administration of the study drug
Adverse event
12 secondary outcomes
ORR-EoT
Time frame: Every 6 weeks，assessed up to 6 treatment cycles (each cycle is 21 days).
PFS
Time frame: 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
OS
Time frame: From date of administration until date of death from any cause, assessed up to 24 months.
CBR
Time frame: Every 6 weeks，assessed up to 24 months.
DOR
Time frame: Every 6 weeks，assessed up to 24 months.
DCR
Time frame: Every 6 weeks，assessed up to 24 months.
TTR
Time frame: Every 6 weeks，assessed up to 24 months.
Tmax
Time frame: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
Cmax
Time frame: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
t1/2
Time frame: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
AUC0-t
Time frame: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
CL
Time frame: From 1 hour before dosing on day 1 and day 12 of the first cycle to 48 hours after dosing, and from 1 hour before dosing on day 8 and day 10 of the first cycle (each cycle is 21 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, Phd principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEBT-908 for Injection, Rituximab Injection and Gemcitabine Hydrochloride for Injection in people with Relapsed/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 16 inclusion and 36 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kegang Jiang, Master (+86-18664786382, kjiang@bebettermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Every 6 weeks，assessed up to 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.