Phase 2
N=30
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
GVHD, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT04930562 ↗Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Nov 2023
Primary outcome: Primary: Overall Response Rate (ORR) — 73.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BN101 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioNova Pharmaceuticals (Shanghai) LTD.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
73.3 | — |
| SECONDARY Duration of Response (DOR) |
20.2 | — |
| SECONDARY Time-to-Response (TTR) |
4.29 | — |
| SECONDARY Number of Participants With Best Response in Each Individual Organ |
8; 6; 12; 3; 2; 6 | — |
| SECONDARY Number of Participants With Change From Baseline in Overall Score on Lee cGvHD Symptom Scale at Specified Time Points |
15; 10 | — |
| SECONDARY Failure-free Survival (FFS) |
NA | — |
| SECONDARY Time to Next Therapy (TTNT) |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Change From Baseline in Corticosteroids Dose |
0.277 | — |
| SECONDARY Number of Participants With Change From Baseline in Calcineurin Inhibitor (CNI) Usage. |
7; 3 | — |
| SECONDARY Change From Baseline in in Global Severity Rating (GSR) Score by Clinician-reported cGVHD Assessment |
5.4 | — |
| SECONDARY Change From Baseline in Symptom Activity by cGVHD Activity Assessment Participant Self-Report |
2.8 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04930562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.