NCT05263583

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cothera Bioscience, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

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

Interventions

Type	Name	Description
DRUG	Sepantronium Bromide	continuous intravenous infusion

Timeline

• Start date: 2022-12-09
• Primary completion: 2025-03-01
• Completion: 2025-06-30
• First posted: 2022-03-02
• Last updated: 2025-01-14

Locations

11 sites across 2 countries: China, South Korea

Regulatory

• FDA-regulated drug study