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Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT06164327 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-12-11

No results posted yet for this study

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).

Conditions

  • Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

DRUG

BEBT-908 for Injection

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.

DRUG

Rituximab Injection

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.

DRUG

Gemcitabine Hydrochloride for Injection

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.

DRUG

Oxaliplatin Injection

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.

DRUG

Etoposide Injection

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.

DRUG

Ifosfamide for Injection

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.

DRUG

Carboplatin Injection

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.

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi, Phd · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-10-31
Completion
2025-11-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164327 on ClinicalTrials.gov