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

Sponsor
BeBetter Med Inc
Study ID
NCT06164327
Phase
PHASE1
Status
Unknown

Conditions

  • Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BEBT-908 for Injection — DRUG
    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 Injection — DRUG
    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 Injection — DRUG
    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 Injection — DRUG
    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 Injection — DRUG
    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 Injection — DRUG
    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 Injection — DRUG
    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 Details

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).

Key Dates

First listed
Dec 11, 2023
Start date
Dec 1, 2023
Status verified
Dec 2023
Primary completion
Oct 31, 2025
Completion
Nov 5, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

ORR [ Time Frame: Every 6 weeks，assessed up to 24 months. ]

Central Contacts

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