High-grade B-cell LymphomaPhase 2NCT05263583
Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
A Phase 2 study testing Sepantronium Bromide in people with High-grade B-cell Lymphoma and Burkitt Lymphoma, run by Cothera Bioscience, Inc at 11 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High-grade B-cell Lymphoma, Burkitt Lymphoma, Lymphoma, B-Cell
- What is being tested?
- Sepantronium Bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 3 Dec 2022to 12 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Radiotherapy within prior 4 weeks
- Requires systemic immunosuppressive therapy
- Positive for Hepatis B or Hepatis C
- Seropositive for HIV
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
China6 sites
Beijing Cancer Hospital
Beijing
Sun Yat-sen University Cancer Center
Guangzhou
Henan Cancer Hospital
Henan
Shanghai East Hospital
Pudong
Tianjin Cancer Hospital
Tianjin
Tongji Hospital
Wuhan
South Korea5 sites
Dong-A University Hospital
Busan
Inje University Haeundae Paik hospital
Busan
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St.Mary's Hospital
Seoul
About this study
Official title: 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
Read the 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
- Being tested
- Sepantronium Bromide
- Keywords
- Relapsed/refractory
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphatic Diseases, Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepantronium BromideDrug
Also called PC-002
continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide Receives: Drug: Sepantronium Bromide |
| Cohort 2 | Experimental | Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide Receives: Drug: Sepantronium Bromide |
| Recommended Phase 2 Dose - Cohort 3 | Experimental | The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 Receives: Drug: Sepantronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions
Measured: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
Secondary outcomes (6)
Overall response rate
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
Measured: From first dose through the last dose of study drug, an average of 6 months
Complete response rate
Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase
Measured: From first dose of study drug through the last dose of study drug, an average of 6 months
Duration of response
Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression
Measured: From first dose of study drug through to time of progression, an average of 6 months
Clinical benefit rate
Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase
Measured: From first dose of study drug through the last dose of study drug, an average of 6 months
Overall survival
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
Measured: From first dose of study drug through date of death, irrespective of cause, an average of 6 months
Progression Free Survival
The time from first dose until relapse, disease progression or death due to any cause
Measured: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start3 Dec 2022
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose range findings study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cothera Bioscience, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vernon Jiang, PhD, Study director, Cothera Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263583
- Sponsor's protocol ID
- PC002-01
- Status last verified
- Nov 2026
- First submitted
- 16 Feb 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05263583
- Acronym / sponsor ID
- PC002-01
- Conditions
- High-grade B-cell Lymphoma, Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphatic Diseases, Lymphoma, High-Grade
- Keywords
- Relapsed/refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cothera Bioscience, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose range findings study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Sepantronium BromideCohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
| Cohort 2 | Experimental | Drug: Sepantronium BromideCohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
| Recommended Phase 2 Dose - Cohort 3 | Experimental | Drug: Sepantronium BromideThe recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sepantronium BromideAlso: PC-002continuous intravenous infusion | Drug | Cohort 1, Cohort 2, Recommended Phase 2 Dose - Cohort 3 |
Primary outcome
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
6 secondary outcomes
Overall response rate
Time frame: 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
Duration of response
Time frame: 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
Overall survival
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernon Jiang, PhD study director
Cothera Bioscience
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sepantronium Bromide in people with High-grade B-cell Lymphoma and Burkitt Lymphoma, run by Cothera Bioscience, Inc at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.