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

January 11, 2025 updated by: Cothera Bioscience, Inc

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer hospital
      • Guangzhou, China
        • Sun yat-sen University Cancer Center
      • Henan, China
        • Henan Cancer Hospital
      • Pudong, China
        • Shanghai East Hospital
      • Tianjin, China
        • Tianjin Cancer Hospital
      • Wuhan, China
        • Tongji Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Dong-A University Hospital
      • Busan, Korea, Republic of
        • Inje University Haeundae Paik Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide
Drug: Sepantronium Bromide
continuous intravenous infusion
Other Names:
  • PC-002
Experimental: Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide
Drug: Sepantronium Bromide
continuous intravenous infusion
Other Names:
  • PC-002
Experimental: Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2
Drug: Sepantronium Bromide
continuous intravenous infusion
Other Names:
  • PC-002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
Time Frame: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions
From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: From first dose through the last dose of study drug, an average of 6 months
The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase
From first dose through the last dose of study drug, an average of 6 months
Complete response rate
Time Frame: From first dose of study drug through the last dose of study drug, an average of 6 months
Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase
From first dose of study drug through the last dose of study drug, an average of 6 months
Duration of response
Time Frame: From first dose of study drug through to time of progression, an average of 6 months
Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression
From first dose of study drug through to time of progression, an average of 6 months
Clinical benefit rate
Time Frame: From first dose of study drug through the last dose of study drug, an average of 6 months
Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase
From first dose of study drug through the last dose of study drug, an average of 6 months
Overall survival
Time Frame: From first dose of study drug through date of death, irrespective of cause, an average of 6 months
The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients
From first dose of study drug through date of death, irrespective of cause, an average of 6 months
Progression Free Survival
Time Frame: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
The time from first dose until relapse, disease progression or death due to any cause
From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cothera Bioscience, Inc

Investigators

  • Study Director: Vernon Jiang, PhD, Cothera Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC002-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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