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

This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.

Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.

Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.

An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.

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