Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD) (ALD518-010)

CSL Behring

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Acute GvHD

Treatments: Biological: ALD518

Study type: Interventional

Funder types: Industry

Identifiers

NCT01530256

ALD518-CLIN-010

Details and patient eligibility

About

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glucocorticosteroid refractory acute GVHD Grade 2-4
• Prior corticosteroid therapy at > 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
• Karnofsky Performance Satus Scale ≥ 50%
• Adequate laboratory testing at screening

Exclusion criteria

• Subjects having Stage 1 skin acute GVHD
• Subjects with Stage 3 or 4 liver GVHD
• Prior EBV associated malignancy
• Prior or current Hepatitis B or C
• Prior or active tuberculosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

ALD518

Experimental group

Treatment:

Biological: ALD518

Biological: ALD518

Biological: ALD518