Status:
COMPLETED
Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis
Lead Sponsor:
Corestemchemon, Inc.
Collaborating Sponsors:
Hanyang University
Conditions:
Lupus Nephritis
Eligibility:
All Genders
17-70 years
Brief Summary
This observation study is planned to evaluate the safety and efficacy of the subjects who received CS20AT04 in the phase 1 clinical trial. If the subjects who participated in the phase 1 clinical tri...
Detailed Description
Lupus is a representative autoimmune disease that affects the whole body. It is occurred by generation of autoantibody and immune complex due to abnormal activation of the immune cells on the basis of...
Eligibility Criteria
Inclusion
- A Person who enrolled in a phase 1 clinical trial using CS20AT04 (CS20AT04-LN101) and administered CS20AT04 and has been 3 months.
- A person who voluntarily consent to participate in this observational study
- \*Phase I clinical trial Inclusion Criteria
- Patients with HLA-haplo-matched bone marrow donor is less than 70 years old.
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Patients had suffered from active renal disease in the past or patients has active renal disease now. Active renal disese should have include below.
- Spot urine protein/creatinine ratio ≥ 1.0 and ① \>5 RBC/HPF, ② \>5 WBC/HPF, ③ columnar cell.
- Biopsy confirmed active type III or type IV, or type V lupus nephritis. Patients can be immunosuppressive agent to , steroids, taking, such as anti-Malarials (hydroxychloroquine) in a certain capacity, during the test period, to maintain the same capacity before 4-weeks screening.
- Patients who consented to participate in the study in writing by themselves or their legal representatives.
Exclusion
- A person who do not agree to participate in this follow up observational study among the subjects enrolled in a phase 1 clinical trial using CS20AT04.
- \*Phase I clinical trial exclusion criteria
- Those who do not kidney disease for SLE.
- Patients with a history of hypersensitivity, such as heavy metal poisoning similar to drug testing and drug ingredients.
- Patients a history Major organs (kidney, liver, lung, heart) transplant or liver hematopoietic cells / transplant or during of scheduled transplantation clinical trial.
- patients a history of kidney dialysis or during of the scheduled dialysis clinical trials within 2 weeks prior to the screening.
- Tested positive for hepatitis B(HBsAg, Anti-HBcAB, HBV-DNA) and hepatitis C(Anti-HCV, HCV-RNA).
- Patients a history of anaphylactic reaction for the parenteral administration of a monoclonal antibody or contrast agent, a mouse protein or human.
- Patients whose e-GFR ≤ 30mL/min at screening.
- Patients with a history of malignancy within 5 years prior to the screening(basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical intraepithelial neoplasia are excluded).
- Patients who were administered drug of the follow within 6 months prior to the screening.
- nitrogen mustard, chlorambucil, vin·cris·tine, procarbazine, Abatacept, Rituximab, Belimumab Patients who were administered drug of the follow within 3 months prior to the screening.
- Anti-TNF therapy(Etanercept, adalimumab, Infliximab, golimumab, Tocilizumab) Interleukin-1 receptor antagonist(anakinra) Intravenous immunoglobulin(IVIG) Plasmapheresis
- Those who are hypersensitive to antibiotics including penicillin and streptomycin.
- Patients with systemic infection at screening.
- Uncontrolled hypertension or diabetes.
- If that may affect proteinuria increased capacity or begin taking medication(ACE inhibitors, ARB (Angiotensin Receptor Blocker)) (However, more than four weeks allowed capacity, taking is possible during the trial period without changing capacity).
- Patients who showed myocardial infarction or angina on ECG at screening, or received stent procedure or bypass.
- Patients who were administered another study drug 3 months prior to the study.
- Patients with severe mental disease(for example, schizophrenia, bipolar disorder etc;).
- Patients are expected to be administered the combination contraindicated drugs about inevitable or taker within clinical trial.
- Women of childbearing age are not implement adequate contraception during clinical trials. the proper method of contraception, which has Oral contraceptive continued more than four weeks, a surgical procedures including the insertion loop, condom use etc. and Medically it is determined that there is no possibility of pregnant women do not belong to women of childbearing age due to the ovary removal, hysterectomy and menopause, etc.
- Pregnant women or nursing women.
- Except as permitted in the following Case and laboratory test results than moderate adverse events(NCI-CTC (National Cancer Institute-Common Toxicity Criteria) version 4.0) grade 3.
- Class III due to stable prothrombin time of warfarin therapy
- Lupus anticoagulant group, and are not associated with liver disease or stable anticoagulation 3 grade partial thromboplastin time
- Lupus due to hepatitis and alcoholic liver disease, are not associated with uncontrolled diabetes or viral hepatitis stable 3 grade gamma glutamyl transferase (GGT) increases. If it appears to be less than ALT and / or AST is above all on the second level.
- Stable grade 3 neutropenia or white blood cell count
- Patients who previously received stem cell therapy.
- Subjects who by the investigator to make them ineligible for participation in this clinical study.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04522505
Start Date
November 29 2017
End Date
July 22 2024
Last Update
January 10 2025
Active Locations (1)
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1
Hanyang university hospital
Seoul, South Korea, 04763