Clinical trial NCT05263583: Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Keywords: Relapsed/refractory
Lead sponsor: Cothera Bioscience, Inc
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose range findings study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
timeFrame: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
Secondary outcomes:
measure: Overall response rate
timeFrame: From first dose through the last dose of study drug, an average of 6 months
measure: Complete response rate
timeFrame: From first dose of study drug through the last dose of study drug, an average of 6 months
measure: Duration of response
timeFrame: From first dose of study drug through to time of progression, an average of 6 months
measure: Clinical benefit rate
timeFrame: From first dose of study drug through the last dose of study drug, an average of 6 months
measure: Overall survival
timeFrame: From first dose of study drug through date of death, irrespective of cause, an average of 6 months
measure: Progression Free Survival
timeFrame: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Henan
country: China
facility: Henan Cancer Hospital
city: Pudong
country: China
facility: Shanghai East Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Tongji Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
affiliation: Cothera Bioscience
name: Vernon Jiang, PhD
role: STUDY_DIRECTOR
References: