Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Phase 1

• Conditions: Chronic graft-versus-host-disease; MedDRA version: 27.0Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2024-000203-67-Outside-EU/EEA
• Lead Sponsor: Kadmon Corporation, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-30
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female participants at least 12 years of age who have had allogenic hematopoietic cell transplant (HCT).
2.Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD
3.Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
4.Have persistent cGVHD manifestations and systemic therapy is indicated
Karnofsky Performance Score of = 60 (if aged 16 years or older); Lansky
5.Performance Score of = 60 (if aged < 16 years)
6.Weight = 40kg

Are the trial subjects under 18? yes
Number of subjects for this age range: 23
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 221
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1.Participant 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).
2.Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
3.Current treatment with ibrutinib. Prior treatment with ibrutinib is allowed with a washout of at least 28 days prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified