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

November 18, 2019 updated by: Corestem, Inc.

A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • CS20AT04

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment(evaluation)
Time Frame: 28 days after administration
Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG
28 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corestem, Inc.

Collaborators

Hanyang University

Investigators

  • Principal Investigator: SANG-CHEOL BAE, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Actual)

March 12, 2019

Study Completion (Actual)

August 19, 2019

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS20AT04-LN101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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