Frontlight ResearchEarly access
CompletedPhase 2
Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
Key facts
- Who runs it
- Cothera Bioscience, Inc
- Where
- China and South Korea11 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 14 people enrolled
- Started
- 3 Dec 2022
- Ended
- 12 Feb 2025
- Type of study
- Interventional, 3 groups
- Treatments tested
- Sepantronium Bromide
- Record updated
- 4 November 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Allogeneic transplant within 3 months
- Autologous transplant without resolution of post-transplant cytopenias
- Unresolved Grade 2 or greater toxicities from prior anticancer therapy
- Radiotherapy within prior 4 weeks
- Requires systemic immunosuppressive therapy
- Seropositive for HIV
- Average QT/QTc interval duration > 450 msec
- Known CNS involvement
- Inadequate marrow, hepatic or renal function
- Positive for Hepatis B or Hepatis C
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The 3 groups in the trial
- Cohort 1Treatment being tested
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide
Treatment: Sepantronium Bromide
- Cohort 2Treatment being tested
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide
Treatment: Sepantronium Bromide
- Recommended Phase 2 Dose - Cohort 3Treatment being tested
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2
Treatment: Sepantronium Bromide
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)
- Record updated
- 4 November 2026