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

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ClinicalTrials.gov Identifier: NCT03174587
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2017
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Hanyang University
Information provided by (Responsible Party):
Corestem, Inc.

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.


Condition or disease Intervention/treatment Phase
Lupus Nephritis Biological: allogenic bone marrow derived mesenchymal stem cells Phase 1

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 abnormal immune responses.

Although about 50% of lupus patients have lupus nephritis, there is no therapy product targeted for the lupus nephritis now.

We have performed the pre-clinical and clinical studies using allogenic bone marrow derived mesenchymal stem cells in SLE.

CS20AT04 has anti-inflammatory effects, controls activity of immune cells and reduces generation of autoantibodies. So, it is expected to have treatment effects of lupus nephritis.

The clinical trial was designed as a single center, open-label, phase 1 clinical trials.

If that subject's written informed consent form to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol within 56 days investigational drug administration.

Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.

Check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 3 days, 7 days and 28 days.

Except for dose administration, all subject are tested in the same schedule. As a result of evaluating severity of AE divided into grades in accordance with the CTCAE (Version 4.0) standards.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS20AT04
Test group : CS20AT04 (allogenic bone marrow derived mesenchymal stem cells.)
Biological: allogenic bone marrow derived mesenchymal stem cells
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
Other Name: CS20AT04




Primary Outcome Measures :
  1. Safety assessment(evaluation) [ Time Frame: 28 days after administration ]
    Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

    1. Spot urine protein/creatinine ratio ≥ 1.0 and ① >5 RBC/HPF, ② >5 WBC/HPF, ③ columnar cell.
    2. 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 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.

    • proteinuria
    • hematuria
    • pyuria
    • Columnar
    • Hypoalbuminemia caused by lupus nephritis
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174587


Locations
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Korea, Republic of
Hanyang university hospital
Seoul, Korea, Republic of, 04763
Sponsors and Collaborators
Corestem, Inc.
Hanyang University
Investigators
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Principal Investigator: SANG-CHEOL BAE Hanyang University

Additional Information:
Publications:
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Responsible Party: Corestem, Inc.
ClinicalTrials.gov Identifier: NCT03174587     History of Changes
Other Study ID Numbers: CS20AT04-LN101
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corestem, Inc.:
Systemic lupus erythematosus
HLA-haplo-matching
allogenic bone marrow derived mesenchymal stem cell
Phase 1 clinical trial

Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases