Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)

NCT04930562 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BN101-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

GVHD, Chronic

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  OR was defined as the percentage of participants with complete response (CR) or partial response (PR). The OR determination of chronic graft versus host disease (cGVHD) was based on cGVHD response assessment performed by clinicians as per the 2014 National Institutes of Health (NIH) Consensus Development Project for Clinical Trials in cGVHD criteria. CR was defined as the resolution of all manifestations in each organ or site. PR was defined as the improvement in at least 1 organ or site without progression in any other organ or site; and cGVHD progression was defined as the clinically meaningful worsening in 1 or more organs regardless of improvement in other organs.

  12 Months

Secondary Outcomes (11)

• Duration of Response (DOR)

  12 Months

• Time-to-Response (TTR)

  12 months

• Number of Participants With Best Response in Each Individual Organ

  12 months

• Number of Participants With Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points

  Baseline and 12 months

• Failure-free Survival (FFS)

  12 months

Study Arms (1)

200mg qd

EXPERIMENTAL

200mg qd po.

Drug: BN101

Interventions

BN101 DRUG

BN101 is an orally ROCK2 selective inhibitor

Also known as: belumosudil, KD025

200mg qd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioNova Pharmaceuticals (Shanghai) LTD.: lead

Study Sites (7)

Peking University People's Hospital

Beijing, China

Location

Xinqiao Hospital, Army Medical University

Chongqing, China

Location

Guangzhou First People's Hospital

Guangzhou, China

Location

Nanfang Hospital

Guangzhou, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

Related Publications (1)

• Wang Y, Wu D, Zhang X, Li Y, He Y, Liu Q, Xuan L, Li Z, Qi K, Sun Y, Wang S, Mo W, Gao L, Hua Y, Wang Y, Zhang Y. A phase II study of belumosudil for chronic graft-versus-host disease in patients who failed at least one line of systemic therapy in China. BMC Med. 2024 Mar 26;22(1):142. doi: 10.1186/s12916-024-03348-5.

  PMID: 38532458 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

belumosudil; KD025

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: BioNova Pharmaceutical Limited Company

yu.wang@bionovapharma.com

+86(21)50901280

Study Officials

• Depei Wu, Prof

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: April 27, 2021
• Primary Completion: June 10, 2022
• Study Completion: December 10, 2022
• Last Updated: January 17, 2024
• Results First Posted: November 1, 2023

Record last verified: 2023-12

Locations

CN (7)