Phase 2
Completed N=30
Efficacy and Safety of BN101 in Subjects With Chronic Graft Versus Host Disease (cGVHD)
GVHD, Chronic
Source: ClinicalTrials.gov NCT04930562 ↗
Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Nov 2023
Primary outcomePrimary: Overall Response Rate (ORR) — 73.3 percentage of participants
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.
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 | — |
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. Informational only — not medical advice.