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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 Diffuse Large B-Cell Lymphoma (R/R DLBCL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Kegang Jiang, Master
kjiang@bebettermed.com
+86-18664786382
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-11-05
Participants
Target number of participants: 75
Treatments
Experimental: BEBT-908 combined with R
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.
Experimental: BEBT-908 combined with R-GemOx
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.
Experimental: BEBT-908 combined with R-ICE
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.
Experimental: BEBE-908 monotherapy (alternative cohort 1)
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.
Experimental: BEBT-908 combined with R-GemOx(alternative cohort 2)
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.
Sponsors
Leads: BeBetter Med Inc

This content was sourced from clinicaltrials.gov

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