A Phase 2 interventional study of CS20AT04 (allogenic bone marrow derived mesenchymal stem cell) in Systemic Lupus Erythematosus, sponsored by Hanyang University Seoul Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Hanyang University Seoul Hospital · Phase 2, Interventional, and Treatment
Among 30 studies in Lupus Nephritis with a site in Korea, Republic of — 5 open to participants now, 8 under way, 2 of them phase 3. Lupus Nephritis · Korea, Republic of.
Among the 30 studies in Lupus Nephritis with a site in Korea, Republic of, this one is the 26th largest by planned enrollment of the 28 interventional ones that give a count, is one of 3 that started in 2019, is one of 14 in phase 2, and was the 20th registered.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
Browse Lupus Nephritis studies →5 of the 30 studies in Lupus Nephritis with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in Korea, Republic of, United States, France and 3 more countries
Novartis Pharmaceuticals · Sites in Korea, Republic of, United States, Brazil and 15 more countries
Seoul National University Hospital · Sites in Korea, Republic of
Kite, A Gilead Company · Sites in Korea, Republic of, United States, Australia and 1 more country
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 15 · Phase 3 8 · Phase 4 1
First in 2004; this study’s year is marked. 3 started in 2019.
This study's planned enrollment of 10 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Median enrollment 95 across the 28 interventional studies, 1,503 across the 2 observational. Of the 21 that completed or were terminated, 16 (76%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 30 have an industry lead sponsor. The 10 most frequent:
Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Hanyang University Seoul Hospital has 1 study filed under Lupus Nephritis — fewer than ten, so there is no comparison to draw.
1 of the studies in Lupus Nephritis with a site in Korea, Republic of that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05126277Phase 3Novartis PharmaceuticalsSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | 2027-09-21 |
Among the 30 studies in Lupus Nephritis with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of systemic lupus erythematosus patients - lupus nephritis and lupus cytopenia.
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease of unknown cause that can affect virtually every organ. A subset of SLE patients continues to suffer significant morbidity and mortality from active disease, with visceral organ involvement. Therefore, it is urgent to develop a more effective therapy for SLE disorder, especially for treatment-refractory patients.
Bone marrow-derived mesenchymal stem cells are known to be effective in modulating immune cells such as T lymphocytes, B lymphocytes, dendritic cells, and Neutral Killer (NK) cells and treating acute Graft-Versus-Host Disease (GVHD). Also, based on the anti-inflammatory and immunomodulatory properties, bone marrow-derived mesenchymal stem cells have been widely studied as a candidate for the treatment of refractory immune- and inflammation-mediated disease, and have extensive experience of use.
Half-matched allogeneic bone marrow-derived mesenchymal stem cells, the active ingredient of CS20AT04 Injection, not only have the potential to differentiate into various mesenchymal cells but also have various immunomodulatory and anti-inflammatory effects, and thus are expected to induce and maintain remission of lupus nephritis and lupus cytopenia.
This study is designed to investigate the following. Subjects enrolled into the CS20AT04 with corticosteroid taper regimen arm will receive two infusions of CS20AT04(2.0×10\^6cell/kg), on 0 day and on 12 weeks post-enrollment. Subjects will return for efficacy and safety assessments on 3 days, 1 week, and every 4 weeks each post-infusion until Week 24. Safety monitoring will be continued at 1 year, 3 years, and 5 years post-infusion.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 10 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients meeting:
-at least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, including at least 1 clinical criterion and 1 immunology criterion; or
-at least 4 of the 11 Revised American College of Rheumatology (ACR) Criteria for Classification of Systemic Lupus Erythematosus, according to the 1997 Update of the 1982 ACR
Patients (non-responder or partial responder), defined as :
-unresponsive to treatment with standard care(such as monthly i.v. pulse cyclophosphamide (CYC) 500-1000 mg/m2, mycophenolate (MMF) ≥ 2 gm/day, azathioprine (AZA) ≥ 200 mg/day, leflunomide (LEF) 20 mg/day, oral CYC, cyclosporine, mizoribine ≥ 150 mg/day, mycophenolic acid ≥ 1.44 g/day, tacrolimus (TAC) ≥ 1.5 mg twice a day alone or in combination for at least 6 months) or
-with continued daily dosage of ≥15mg of prednisone or its equivalent for maintenance treatment
5-1. For the lupus cytopenia sub-group only:
[Red blood cell associated] -Hemolytic anemia ( ≤ 10g/dL) with reticulocytosis, or [White cell associated]
- \< 1,000/mm3 (in the absence of other known cause such as , drugs, and infection), and/or
5-2. For the lupus nephritis sub-group only: •Patients with clinical disease activity of lupus nephritis, defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects enrolled into the CS20AT04 with corticosteroid taper regimen arm will receive two infusions of CS20AT04 (2.0×10\^6cell/kg), on 0 day and on 12 weeks post-enrollment.
Biological: CS20AT04 (allogenic bone marrow derived mesenchymal stem cell)
Two intravenous infusions of CS20AT04 (2.0×10\^6cell/kg), on 0 day and on 12 weeks The target population of this study is subjects in South Korea with a diagnosis of either lupus nephritis or lupus cytopenia.
Reduction of corticosteroid dose to ≤ 7.5 mg/day of prednisone or equivalent
The primary efficacy objective of this study is to assess the efficacy of CS20AT04, in combination with a 24-week corticosteroid taper regimen, as measured by: Reduction of corticosteroid dose to ≤ 7.5 mg/day of prednisone or equivalent at Week 4 , and continued through Week 12
Time frame: 24 weeks
Hematologic improvement without ongoing SLE treatment
As Lupus cytopenia sub-group specific endpoint, Hgb increase of ≥ 1.5 g/dL, or Neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of 500/mm3 x 10\^9/L, or For pre-treatment platelet count \> 20 X 10\^9/L, a platelet absolute increase of ≥ 30 X 10\^9/L For pre-treatment platelet count ≤ 20 X 10\^9/L, a platelet absolute increase ≥ 20 X 10\^9/L and ≥ 100% increase from pre-treatment level
Time frame: 24 weeks
Renal response improvement
As Lupus nephritis (LN) sub-group specific endpoint, a renal response at 24 weeks adjudicated based on the following parameters: Urine Protein to Creatinine Ratio (UPCR) of ≤0.5mg/mg, and Estimated Glomerular Filtration Rate (eGFR)≥60mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of \> 20%, and Did not receive any rescue medication for LN, and Did not receive over than 7.5mg prednisone for ≥7 consecutive days in total during week 12 through 24, just prior to the renal response assessment
Time frame: 24 weeks
Proportion of subjects who achieve a prednisone dose of ≤ 7.5mg/day or equivalent
Proportion of subjects who achieve a prednisone dose of ≤ 7.5mg/day or equivalent by Week 12 and maintain this dose ≤ 7.5mg/day prednisone or equivalent from Week 12 to 24
Time frame: 12 weeks, 24 weeks
Proportion of subjects achieving Low Level Disease Activity State
Proportion of subjects achieving Low Level Disease Activity State (LLDAS) at Week 24
Time frame: 24 weeks
Proportion of subjects with ≥ 4 point reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score
Proportion of subjects with ≥ 4 point reduction from baseline in SLEDAI-2K score at 24 weeks
Time frame: 24 weeks
Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 4 having SLE responder index 4 (SRI5)
Proportion of subjects with baseline SLEDAI-2K ≥ 4 having SLE responder index 5 (SRI5) response at 24 weeks, defined by (i) a ≥ 4 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of \< 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24 weeks)
Time frame: 24 weeks
Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 5 having SLE responder index 5 (SRI5)
Proportion of subjects with baseline SLEDAI-2K ≥ 5 having SLE responder index 5 (SRI5) response at 24 weeks, defined by (i) a ≥ 5 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of \< 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24 weeks)
Time frame: 24 weeks
Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 6 having SLE responder index 6 (SRI6)
Proportion of subjects with baseline SLEDAI-2K ≥ 6 having SRI6 response at 24 weeks, defined by (i) a ≥ 6 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of \< 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24weeks)
Time frame: 24 weeks
Time to first severe modified SLE Flare Index (SFI) flare
Time to first severe modified SLE Flare Index (SFI) flare over 24 weeks
Time frame: 24 weeks
Change from baseline of hematologic parameters
For the lupus cytopenia sub-group only: Change from baseline of hematologic parameters (white blood cell counts, platelet counts, and hemoglobin) at 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks
Time frame: 3 days, 1 week, 4 weeks, 12 weeks , and 24 weeks
Time to first hematologic flare
For the lupus cytopenia sub-group only: Time to first hematologic flare over 24 weeks
Time frame: 24 weeks
Change in baseline of renal function parameters
For the lupus nephritis sub-group only: Time to event for each of the individual components of treatment failure (death, ESRD, sustained doubling of serum creatinine, renal flare, extrarenal flare, or rescue therapy)
Time frame: 24 weeks
Time to event for each of the individual components of treatment failure
For the lupus nephritis sub-group only: Time to event for each of the individual components of treatment failure (death, End-Stage Renal Disease (ESRD), sustained doubling of serum creatinine, renal flare, extrarenal flare, or rescue therapy)
Time frame: 24 weeks
Time to complete remission
For the lupus nephritis sub-group only: Time to complete remission over 24 weeks, as defined by return to normal values of serum creatinine (\< 106 μmol/L), proteinuria (\< 0.3 g/24 h), and urine sediment.
Time frame: 24 weeks
Time to first renal flare
For the lupus nephritis sub-group only: Time to first renal flare over 24 weeks
Time frame: 24 weeks
Change in SLE parameters compare to baseline
Change in the following SLE parameters compared to baseline at 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks: * Total Systemic Lupus Erythematosus Disease Activity Index- 2000 (SLEDAI-2K) score * Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR-DI) score * British Isles Lupus Assessment Group (BILAG) scale (at 4 weeks, 12 weeks, and 24 weeks)
Time frame: 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks
Change from baseline of Treg CD4+CD25+Foxp3+) and Th17 (CD3+CD8-IL-17A+) cell counts
Change from baseline of Treg (CD4+CD25+Foxp3+) and Th17 (CD3+CD8-IL-17A+) cell counts at 3 days, 1 week, 4 weeks, 12 weeks, 24 weeks and 0.5 years, 1 year, 1.5 years, 2 years, 3 years after the first injection, as measured by flow cytometry (FACS) analysis \* CD=Cluster of Differentiation, Foxp=forkhead box P, IL=Interleukin
Time frame: 3 days, 1 week, 4 weeks, 12 weeks, 24 weeks and 0.5 years, 1 year, 1.5 years, 2 years, 3 years
Started Sep 2019 (actual). Primary completion is estimated for Nov 2021, 25 months after the start.
Of 33 phase 2 interventional studies under Lupus Nephritis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 57. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
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Hanyang University Seoul Hospital