A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

STATUS

Recruiting
participants needed

60
sponsor

Innovent Biologics (Suzhou) Co. Ltd.

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Updated on 19 February 2024

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cancer

corticosteroids

growth factor

stem cell transplantation

graft versus host disease

hematologic malignancy

acute graft versus host disease

itacitinib

Summary

The purpose of this study is to evaluate itacitinib in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Description

This is an open label, single-arm, multicenter Phase I/II study of IBI377 in combination with corticosteroids as first-line treatment of subjects with Grade II to IV aGVHD. In Phase I, the PK, safety, tolerability and efficacy of IBI377 will be assessed in 12 subjects. In Phase II, the efficacy and safety will be assessed in 48 subjects.

Details

Condition	GVHD,Acute
Age	18years - 100years
Treatment	Methylprednisolone, Prednisone, Itacitinib
Clinical Study Identifier	NCT04220632
Sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Has undergone 1 allo-HSCT(hematopoietic stem cell transplantation) from any donor (related or unrelated with any degree of HLA(human leukocyte antigen) matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible
	Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen
	Evidence of myeloid engraftment. Use of growth factor supplementation is allowed
	Serum creatinine 2.0 mg/dL or creatinine clearance 40 mL/min measured or calculated by Cockroft Gault equation
	Willing to avoid pregnancy or fathering children
	Able to give written informed consent and comply with all study visits and procedures
	Able to swallow and retain oral medication
Exclusion Criteria
	Has received more than 1 allo-HSCT
	Has received more than 2 days of systemic corticosteroids for acute-GVHD
	Presence of GVHD overlap syndrome
	Presence of an active uncontrolled infection
	Known human immunodeficiency virus infection
	Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation
	Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed
	Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization
	Severe organ dysfunction unrelated to underlying GVHD, including
	Cholestatic disorders or unresolved veno-occlusive disease of the liver
	Clinically significant or uncontrolled cardiac disease
	Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen
	Currently breast feeding
	Received JAK(Janus kinase) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted
	Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment
	Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
	Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

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A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease