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

NCT06074107 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-10-11

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

BEBT-908 for injection

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.

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2023-12-20
Completion
2023-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06074107 on ClinicalTrials.gov