Status:
UNKNOWN
Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
BeBetter Med Inc
Conditions:
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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-G...
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 acc...
Eligibility Criteria
Inclusion
- 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;
- 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).
Exclusion
- 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.);
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06164327
Start Date
December 1 2023
End Date
November 5 2025
Last Update
December 11 2023
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021