Back to resultsEfficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
Primary Purpose
GVHD, Chronic
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BN101
Sponsored by
About this trial
This is an interventional treatment trial for GVHD, Chronic
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects at least 18 years of age who have had allogenic hematopoietic cell transplant (HCT).
- Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD
- Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening;
- Have persistent cGVHD manifestations and systemic therapy is indicated
Exclusion Criteria:
- Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
- Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
- Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to treatment.
Sites / Locations
- Peking University People's Hospital
- Xinqiao Hospital, Army Medical University
- Guangzhou First People's Hospital
- Nanfang Hospital
- Zhujiang Hospital of Southern Medical University
- Lu Daopei Medical
- The First Affiliated Hospital of Soochow University
- The Affiliated Hospital of Xuzhou Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
200mg qd
Arm Description
200mg qd po.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
The primary endpoint is the ORR with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.
Secondary Outcome Measures
Full Information
NCT ID
NCT04930562
First Posted
June 11, 2021
Last Updated
April 13, 2023
Sponsor
BioNova Pharmaceuticals (Shanghai) LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04930562
Brief Title
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
Official Title
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of BN101 in Subject With Chronic Graft Versus Host Disease (cGVHD) After at Least Fist Line of Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNova Pharmaceuticals (Shanghai) LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of systemic therapy.
Detailed Description
Approximately 30 subjects will be enrolled to receive orally administered BN101 200 mg QD (once daily)
Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity. Subjects may receive study drug in the inpatient or outpatient setting.
Curative Effect analysis The efficacy was analyzed based on MITT The point estimate and 95%CI of ORR were calculated based on the exact probability method of binomial distribution.If applicable, a logistic regression model will be used for multivariate analysis.
Descriptive statistical analyses were provided for all secondary efficacy endpoints.
The following subgroups will be analysed:
Severe cGVHD (Yes/No)
Number of organs involved (<4 vs. ≥4)
Number of previous systemic cGVHD treatment (1 vs. ≥2)
Duration of cGVHD before inclusion (i.e., from the time of cGVHD diagnosis to the time of inclusion)
Lung Involvement (Yes/No)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GVHD, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
200mg qd
Arm Type
Experimental
Arm Description
200mg qd po.
Intervention Type
Drug
Intervention Name(s)
BN101
Other Intervention Name(s)
belumosudil, KD025
Intervention Description
BN101 is an orally ROCK2 selective inhibitor
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
The primary endpoint is the ORR with responses as defined by the 2014 National Institute of Health (NIH) Consensus Development Project on clinical trials in cGVHD.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects at least 18 years of age who have had allogenic hematopoietic cell transplant (HCT).
Previously received at least 1 and not more than 5 lines of systemic therapy for cGVHD
Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening;
Have persistent cGVHD manifestations and systemic therapy is indicated
Exclusion Criteria:
Subject has not been on a stable dose / regimen of systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and extracorporeal photophoresis (ECP) are acceptable. Systemic investigational GVHD treatments are not permitted).
Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, Prof
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Xinqiao Hospital, Army Medical University
City
Chongqing
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
Country
China
Facility Name
Lu Daopei Medical
City
Hebei
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
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