Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease

SCM Lifescience

Status and phase

Active, not recruiting

Phase 2

Conditions

Chronic Graft-versus-host-disease

Treatments

Biological: SCM-CGH

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04189432

SCM-CGH2001

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial response [PR] defined by National Institutes of Health [NIH] consensus development project criteria [2014]).

Enrollment

84 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who are males or females aged >= 19 years, 40kg to 80kg in weight
Steroid dependent/refractory chronic graft versus host disease (cGVHD) defined as the National Institutes of Health (NIH) criteria (2014) below at any time post-hematopoietic cell transplant (post-HCT):

Refractory disease, defined as, 1) when cGVHD manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at >=1 mg/kg/day for at least 2 weeks) or 2), 3) Persist without improvement despite continued treatment with glucocorticoid (prednisolone at >=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks Dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to [>=] 0.25 milligram per kilogram per day (mg/kg/day)or >=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks.

Participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cGVHD for at least 4 weeks before Screening visit. The dose of steroids or Immunosuppressant must be stable for 14 days(2 weeks) prior to starting SCM-CGH or Placebo.
Laboratory test sufficiency as follows; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Serum creatinine < 2 x upper limit of normal (ULN)

Exclusion criteria

Active acute graft versus host disease (GVHD)
Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
Uncontrolled underlying disease such as moderate or severe infections and hemorrhage
Severe Heart failure (NYHA class III/IV), congestive heart failure or arrhythmia requiring treatment
History of allogenic hematopoietic stem cell more than once
Positive reaction of a Penicillin test at screening
History of relapse of causative diseases (ALL, CML, CLL, AML, NHL, multiple myeloma e.t.c.) with hematopoietic stem cell transplantation or diagnosed with secondary malignant diseases after hematopoietic stem cell transplantation
History of Anti-thymocyte globulin(ATG) for 2 weeks before Screening visit
History of pulmonary embolism or deep venous thrombosis for 24 weeks before Screening visit