Active — Not RecruitingPhase 2

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

China14 participantsStarted 2022-12-09

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Safety and tolerability and recommended Phase 2 dose of sepantronium bromide

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

Trial details

NCT IDNCT05263583

SponsorCothera Bioscience, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More High-grade B-cell Lymphoma trials