Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis

NCT03174587 | Completed Phase 1

• 1 other identifier: CS20AT04-LN101
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis. Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.

Conditions

Lupus Nephritis

Keywords

Systemic lupus erythematosus; HLA-haplo-matching; allogenic bone marrow derived mesenchymal stem cell; Phase 1 clinical trial

Outcome Measures

Primary Outcomes (1)

• Safety assessment(evaluation)

  Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG

  28 days after administration

Study Arms (1)

CS20AT04

EXPERIMENTAL

Test group : CS20AT04 (allogenic bone marrow derived mesenchymal stem cells.)

Biological: allogenic bone marrow derived mesenchymal stem cells

Interventions

allogenic bone marrow derived mesenchymal stem cells BIOLOGICAL

Step -1 dose : 1.0x10\^6cells/kg Step 1 dose : 2.0x10\^6cells/kg Step 2 dose : 3.0x10\^6cells/kg The single injection of CS20AT04 Inj. in the peripheral veins.(IV) The duration of follow up study following the single dose of CS20AT04 is 28 days

Also known as: CS20AT04

CS20AT04

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female Patients aged ≥18 years and \< 70years.
• 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:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hanyang university hospital

Seoul, 04763, South Korea

Location

Related Publications (2)

• Jang E, Jeong M, Kim S, Jang K, Kang BK, Lee DY, Bae SC, Kim KS, Youn J. Infusion of Human Bone Marrow-Derived Mesenchymal Stem Cells Alleviates Autoimmune Nephritis in a Lupus Model by Suppressing Follicular Helper T-Cell Development. Cell Transplant. 2016;25(1):1-15. doi: 10.3727/096368915X688173. Epub 2015 May 13.

  PMID: 25975931 BACKGROUND

• Shim JS, Sung YK, Joo YB, Lee HS, Bae SC. Prevalence and incidence of systemic lupus erythematosus in South Korea. Rheumatol Int. 2014 Jul;34(7):909-17. doi: 10.1007/s00296-013-2915-9. Epub 2013 Dec 10.

  PMID: 24322455 BACKGROUND

Related Links

• Corestem Inc.

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

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: May 30, 2017
• Primary Completion: March 12, 2019
• Study Completion: August 19, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)