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

NCT06074107 | Unknown Phase 2

• 1 other identifier: GBMT-908-P02
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Relapsed or Refractory Diffuse Large B-cell Lymphoma

Keywords

BEBT-908; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  6 weeks， assessed up to 24 months.

Secondary Outcomes (6)

• DCR

  Every 6 weeks， assessed up to 24 months.

• PFS

  From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

• TTR

  From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

• DOR

  From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

• OS

  From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Study Arms (1)

BEBT-908 for injection

EXPERIMENTAL

BEBT-908 for injection, dosage form: injection, specification: 25mg, administration method: the initial dose was 22.5mg/m2, intravenous drip, 3 times a week, 21 days as a cycle, 6 cycles as the total treatment cycle.

Drug: BEBT-908 for injection

Interventions

BEBT-908 for injection DRUG

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.

Also known as: CUDC-908

BEBT-908 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is willing to sign the informed consent form (ICF) after a comprehensive understanding.
• Age ≥ 18 years and ≤ 75 years, male or female.
• Diffuse large B-cell lymphoma was confirmed by central pathological examination and tissue biopsy.(Note 1)
• With measurable lesions.(Note 2)
• Refractory or relapse after at least two kinds of systematic treatment. (Note 3)
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
• 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) ≥ 1000000 /μL.
• Liver function:
• Serum total bilirubin ≤ 1.5 × Upper limit of normal value （ULN） (for patients with Gilbert syndrome, total bilirubin \< 3.0 × ULN and direct bilirubin within the normal range).
• Serum creatinine \< 1.5 × ULN.

You may not qualify if:

• It is known to be severely allergic to research drugs or any of their excipients.
• Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded:
• Men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial. Unless follow-up studies confirm reproductive safety.
• pregnant or lactating women.
• Primary central nervous system lymphoma or lymphoma invading the central nervous system.
• Previous transformation of chronic lymphoma (such as Richter syndrome, pre-lymphocytic leukemia, etc.).
• There are other active malignant tumors that may interfere with this study.
• Pre-trial treatment:
• Have received any persistent or intermittent treatment such as Phosphoinositide 3-kinase (PI3K) inhibitors, Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors or other small molecule targeted drugs within 2 weeks before entering the group.
• Autologous hematopoietic stem cell transplantation within 3 months before enrollment.
• Received radiotherapy that affected the efficacy evaluation of this study or local supportive radiotherapy that affected the bone marrow function of the subjects within 3 months before enrollment.
• Bone marrow inhibitory chemotherapy or biotherapy was performed within 3 weeks before enrollment.
• Major surgery other than tumor biopsy was performed within 4 weeks before enrollment, or the side effects of the operation were not stable.
• Received any hematopoietic colony-stimulating factor therapy (such as granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF)) or thrombopoietin （TPO） within 2 weeks before enrollment. (Note 1)
• received prednisone daily \> 10mg (or other dose-effective corticosteroids) within 7 days before enrollment. (Note 2)

Sponsors & Collaborators

• BeBetter Med Inc: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Large B-Cell, Diffuse

Interventions

BEBT-908; Injections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yuankai Shi, Phd

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: June 12, 2020
• Primary Completion: December 20, 2023
• Study Completion: December 25, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)