Long-term Follow-up for Evaluating the Safety of CS20AT04 in Subject with Lupus Nephritis

NCT04522505 | Completed DMC

• 1 other identifier: CS20AT04-LN101-E
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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 trial voluntarily agree to participate in this observation study, visit 1 and visit 2 will be conducted every 3 months according to the clinical trial protocol until 6 months after administration of CS20AT04 in the phase 1 clinical trial. And Visit 3 after 6 months, Visit 4\~Visit 7 will be conducted every 12 months. During each visit, subjects are assessed for the efficacy and occurrence of adverse events.

Conditions

Lupus Nephritis

Keywords

Systemic lupus erythematosus; Allogenic bone marrow derived mesenchymal stem cell

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  After the completion of the CS20AT04-LN101 phase 1 trail, new adverse events, including tumor are assessed and detailed information is collected at each visit.

  up to 57 months after enrollment

• Incidence of abnormal results of Physical examination

  Physical examination is performed at each visit. If clinically significant abnormal findings are recorded in the CRF and collected as AEs.

  up to 57 months after enrollment

• Percentage of abnormal Vital signs

  Percentage of abnormal Blood pressure (mmHg) and Pulse rate (beat per minute)

  up to 57 months after enrollment

• Percentage of abnormal results of Laboratory tests

  The following laboratory tests are performed at each visit * Hematology test: WBC, RBC, Hemoglobin, Hematocrit, Platelet count, WBC Diffcount, ESR * Chemistry test : Total protein, Albumin, Total bilirubin, SGOT(AST), SGPT(ALT), rGTP, Sodium, Potassium, BUN, Creatinine, Glucose, Alkaline Phosphatase, Chloride, Total cholesterol, Triglyceride, Uric Acid , CPK, LDH, CRP, Adolase * Urine analysis : Protein, Creatinine, Glucose, Urobilinogen, WBC, RBC, Urine Sediment, Creatinine, Urine albumin creatinine ratio, Urine protein creatinine ratio

  up to 57 months after enrollment

Secondary Outcomes (4)

• SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index-2000)

  up to 57 months after enrollment

• BILAG 2004 (British Isles Lupus Assessment Group 2004)

  up to 57 months after enrollment

• SDI (Systemic Lupus International Collaborating Clinics/Americans College of Rheumatology (SLICC/ACR) Damage Index

  up to 57 months after enrollment

• Disease activity assessed by PGA (Physician Global Assessment)

  up to 57 months after enrollment

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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.

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Corestemchemon, Inc.: lead
• Hanyang University: collaborator

Study Sites (1)

Hanyang university hospital

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• SANG-CHEOL BAE, M.D.,Ph.D.

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: August 21, 2020
• Study Start: November 29, 2017
• Primary Completion: February 7, 2024
• Study Completion: July 22, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

KR (1)