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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNova Pharmaceuticals (Shanghai) LTD.

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.