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

Cothera

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Sepantronium Bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05263583

PC002-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Sepantronium Bromide

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Sepantronium Bromide

Recommended Phase 2 Dose - Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Sepantronium Bromide