Status:
RECRUITING
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
Lead Sponsor:
Hanyang University Seoul Hospital
Collaborating Sponsors:
Corestemchemon, Inc.
Ministry of Health & Welfare, Korea
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of sys...
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease of unknown cause that can affect virtually every organ. A subset of SLE patients continues to suffer significant morbidity and mort...
Eligibility Criteria
Inclusion
- Patients with HLA-haplo-matched bone marrow donor less than 70 years old
- Patients meeting:
- at least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, including at least 1 clinical criterion and 1 immunology criterion; or
- at least 4 of the 11 Revised American College of Rheumatology (ACR) Criteria for Classification of Systemic Lupus Erythematosus, according to the 1997 Update of the 1982 ACR
- Patients having a positive test result for antinuclear antibody (ANA; titer at least 1:80) and/or anti-double stranded DNA antibody (anti-dsDNA Ab) at screening
- Patients (non-responder or partial responder), defined as :
- unresponsive to treatment with standard care(such as monthly i.v. pulse cyclophosphamide (CYC) 500-1000 mg/m2, mycophenolate (MMF) ≥ 2 gm/day, azathioprine (AZA) ≥ 200 mg/day, leflunomide (LEF) 20 mg/day, oral CYC, cyclosporine, mizoribine ≥ 150 mg/day, mycophenolic acid ≥ 1.44 g/day, tacrolimus (TAC) ≥ 1.5 mg twice a day alone or in combination for at least 6 months) or
- with continued daily dosage of ≥15mg of prednisone or its equivalent for maintenance treatment
- 5-1. For the lupus cytopenia sub-group only:
- Patients with refractory cytopenia (at least one of anemia, leukopenia, or thrombocytopenia) in absence of any other identifiable cause, defined as:
- \[Red blood cell associated\] -Hemolytic anemia (Hgb ≤ 10g/dL) with reticulocytosis, or \[White cell associated\]
- Neutrophil count \< 1,000/mm3 (in the absence of other known cause such as corticosteroids, drugs, and infection), and/or
- Lymphocyte count \< 1,500/mm3 \[Platelet associated\]
- Platelet count \< 100,000/mm3 (in the absence of other known cause such as drugs, portal hypertension, and thrombotic thrombocytopenic purpura (TTP))
- 5-2. For the lupus nephritis sub-group only: •Patients with clinical disease activity of lupus nephritis, defined by:
- laboratory tests documented active lupus nephritis three consecutive times: (i) decrease in renal function (serum creatinine \> 106 μmol/L) (ii) increase in proteinuria (defined as urine protein/creatinine ratio (UPC) \> 1), and (iii) deterioration in microscopic hematuria (defined as \> 10 red cells per high power field) in the absence of menstrual hematuria or urinary tract infection at the time of screening or the presence of cellular casts
- renal biopsy documenting lupus nephritis according to the International Society of Nephrology/Renal Pathology Society classification of active or active/chronic lupus nephritis in renal biopsy class III, class IV-S or IV-G, class V, class III + V, or class IV + V (within 1 year)
Exclusion
- 1\. Patients unable or unwilling to provide written informed consent
- 2\. Patients with any history of cancer, allergy, alcohol or substance abuse, active peptic ulcer disease, heart failure, liver disease, and coagulation disorder
- 3\. Patients who have active severe central nervous system (CNS) lupus
- 4\. Patients who have received biologic investigational agents in the past year
- 5\. Patients undergoing intravenous immunoglobulin or plasma exchange therapy
- 6\. Patients who are pregnant or are lactating
- 7\. Patients with any evidence of a major infection
- 8\. For the lupus nephritis sub-group only: Patients with serum creatinine \> 250 μmol/L
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04835883
Start Date
September 26 2019
End Date
January 20 2026
Last Update
April 8 2021
Active Locations (1)
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1
Hanyang University Medical Center
Seoul, South Korea, KS013