Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma

NCT05263583 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PC002-01
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 11

Brief Summary

This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma

Conditions

High-grade B-cell Lymphoma; Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphatic Diseases; Lymphoma, High-Grade; C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma; C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma; C-Myc Gene Rearrangement

Keywords

Relapsed/refractory

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability and recommended Phase 2 dose of sepantronium bromide

  Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions

  From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months

Secondary Outcomes (6)

• Overall response rate

  From first dose through the last dose of study drug, an average of 6 months

• Complete response rate

  From first dose of study drug through the last dose of study drug, an average of 6 months

• Duration of response

  From first dose of study drug through to time of progression, an average of 6 months

• Clinical benefit rate

  From first dose of study drug through the last dose of study drug, an average of 6 months

• Overall survival

  From first dose of study drug through date of death, irrespective of cause, an average of 6 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide

Drug: Sepantronium Bromide

Cohort 2

EXPERIMENTAL

Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide

Drug: Sepantronium Bromide

Recommended Phase 2 Dose - Cohort 3

EXPERIMENTAL

The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2

Drug: Sepantronium Bromide

Interventions

Sepantronium Bromide DRUG

continuous intravenous infusion

Also known as: PC-002

Cohort 1; Cohort 2; Recommended Phase 2 Dose - Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
• Relapse or refractory disease after at least one previous line of therapy
• Measurable disease as defined by 2014 Lugano classification
• ECOG performance status of 0-2
• Acceptable coagulation parameters

You may not qualify if:

• Allogeneic transplant within 3 months
• Autologous transplant without resolution of post-transplant cytopenias
• Known CNS involvement
• Average QT/QTc interval duration \> 450 msec
• Inadequate marrow, hepatic or renal function
• Unresolved Grade 2 or greater toxicities from prior anticancer therapy
• Radiotherapy within prior 4 weeks
• Requires systemic immunosuppressive therapy
• Positive for Hepatis B or Hepatis C
• Seropositive for HIV

Sponsors & Collaborators

• Cothera Bioscience, Inc: lead

Study Sites (11)

Beijing Cancer Hospital

Beijing, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Henan Cancer Hospital

Henan, China

Location

Shanghai East Hospital

Pudong, China

Location

Tianjin Cancer Hospital

Tianjin, China

Location

Tongji Hospital

Wuhan, China

Location

Dong-A University Hospital

Busan, South Korea

Location

Inje University Haeundae Paik hospital

Busan, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphatic Diseases; Lymphoma, Non-Hodgkin; Recurrence

Interventions

sepantronium

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vernon Jiang, PhD

  Cothera Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose range findings study

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 2, 2022
• Study Start: December 9, 2022
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

CN (6); KR (5)