A Phase 1/2 interventional study of CD19 CAR-T cells in Autoimmune Diseases, sponsored by Hebei Senlang Biotechnology Inc., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Hebei Senlang Biotechnology Inc., Ltd. · Phase 1/2, Interventional, and Treatment
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases
This is a single-center, open-label, single-arm, dose-escalation trial. In this study, we will recruit seven kinds of refractory autoimmune diseases including moderate-to-severe Systemic lupus erythematosus (SLE), refractory Pemphigus, refractory Idiopathic inflammatory myopathy (IIM), Systemic sclerosis (SSc), Refractory ANCA-Associated Vasculitis/Nephritis,refractory Rheumatoid arthritis(RA) and moderate-to-severe refractory Psoriasis.
Patients with Refractory Autoimmune Diseases will receive CD19 CAR T cells. The primary objective is to evaluate the safety and efficacy of CD19 CAR T cell therapy in subjects with Refractory Autoimmune Diseases and to determine the optimal biological dose (OBD) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with Refractory Autoimmune Diseases in phase II.
The primary endpoint is to evaluate the incidence and severity of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.A total number of 3o subjects will be enrolled.
802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 541 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Hebei Senlang Biotechnology Inc., Ltd. is the lead sponsor of 40 studies on the registry; 15 are open to participants now.
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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.
1.5.Signed , agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
1.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
1.7.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3/C4, immunoglobulins, antiphospholipid antibodies, etc.
1.8.Meets current international or domestic classification criteria: the 1997 ACR SLE classification criteria OR the 2019 EULAR/ACR SLE classification criteria, and is judged to have moderate-to-severe SLE.
1.9.SELENA-SLEDAI score ≥ 8; PGA ≥ 1; and at least one BILAG-2004 organ-system score of 1A or 2B.
1.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
2.Refractory Idiopathic inflammatory myopathy (IIM) 2.1.Age 18-70 years. 2.2.Estimated life expectancy ≥ 3 months. 2.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 2.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
2.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
2.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
2.7.Fulfillment of the 2017 EULAR/ACR classification criteria for dermatomyositis or polymyositis.
2.8.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
3.Refractory Systemic sclerosis (SSc) 3.1.Age 18-70 years. 3.2.Estimated life expectancy ≥ 3 months. 3.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 3.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
3.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
3.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
3.7.Fulfillment of the 2013 ACR/EULAR classification criteria for systemic sclerosis, with clinical or radiographic evidence of pulmonary involvement.
3.8.Required laboratory tests, including but not limited to: CBC, urinalysis, ANA, anti-dsDNA, ENA panel, C3/C4, immunoglobulins, etc.
3.9.Classification per current international or domestic standards: the 1980 ACR criteria for SSc OR the 2013 ACR/EULAR criteria for SSc.
3.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
4.Refractory Pemphigus 4.1.Age 18-70 years. 4.2.Estimated life expectancy ≥ 3 months. 4.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 4.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
4.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
4.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
4.7.Fulfillment of at least one clinical manifestation plus one histopathological or immunodiagnostic criterion, OR at least two clinical manifestations plus two immunodiagnostic criteria:
4.8.Pemphigus Disease Area Index (PDAI) ≥ 9 (moderate 9-24, severe ≥ 25). 4.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
5.Refractory Moderate-to-Severe Psoriasis 5.1.Age 18-70 years. 5.2.Estimated life expectancy ≥ 3 months. 5.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 5.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
5.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
5.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
5.7.In accordance with the 2023 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis, meets the diagnostic criteria for moderate-to-severe plaque psoriasis: dark-red or infiltrated erythematous plaques covered by white/silvery scales, demonstrating the wax-drip, film, and Auspitz signs.
5.8.At screening: Body Surface Area (BSA) involvement ≥ 10%, Psoriasis Area and Severity Index (PASI) ≥ 10, and static Physician's Global Assessment (sPGA) ≥ 3.
5.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
6.Refractory Moderate-to-Severe Rheumatoid Arthritis 6.1.Age 18-70 years. 6.2.Estimated life expectancy ≥ 3 months. 6.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 6.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
6.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
6.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
6.7.Required laboratory and imaging assessments, including but not limited to: ESR, CRP, rheumatoid factor, ANA, anti-CCP antibodies, and other relevant autoantibodies; bilateral hand/foot radiographs.
6.8.Meets current international or domestic classification criteria: the 1987 ACR criteria for RA OR the 2010 ACR/EULAR criteria for RA.
6.9.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
7.Refractory ANCA-Associated Vasculitis/Nephritis 7.1.Age 18-70 years. 7.2.Estimated life expectancy ≥ 3 months. 7.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 7.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
7.5.Signed informed consent, agreement to the treatment protocol, and willingness to attend follow-up evaluations per schedule.
7.6.Relevant medical history and clinical manifestations: provide a copy of inpatient records from a tertiary hospital or outpatient records and diagnostic certificates within the last 3 months.
7.7.Meets the 2022 ACR/EULAR classification criteria for vasculitis. 7.8.Renal indicating kidney involvement, or clinical manifestations consistent with small-vessel vasculitis together with positive myeloperoxidase (MPO) or proteinase-3 (PR3) antibodies.
7.9.Persistent or newly emerging renal and/or systemic vasculitic manifestations despite maintenance therapy of the same intensity as initial treatment.
7.10.Inadequate response to, or intolerance of, at least 12 weeks of standardized therapy prior to screening.
Exclusion Criteria:
(1) (as determined by the investigator) history of cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases.
(2) Pregnant or lactating women. (3) History of active tuberculosis (TB) infection within 3 years prior to the screening visit.
(4) History of traumatic brain injury, altered consciousness, epilepsy, cerebral ischemia, or any cerebrovascular hemorrhagic disorders.
(5) Prolonged on or history of severe arrhythmias or other significant cardiac disorders.
(6) Active infection (excluding uncomplicated urinary tract infection and bacterial pharyngitis).
(7) Active virus or virus infection. (8) Confirmed positive anti- antibody test. (9) Positive Treponema pallidum antibody test judged by the investigator to be clinically significant.
(10) Any known or suspected congenital or acquired immunodeficiency that may compromise the subject's immune status.
(11) Prior treatment with CD19 CAR-T cell therapy or CD19-targeted antibody drugs.
(12) Prior exposure to any gene therapy. (13) /AST > 3× , or > 2.0× ULN, or serum creatinine > 2× ULN, or \< 30 mL/min.
(14) Any condition that, in the opinion of the investigator, may increase patient risk or interfere with study results.
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 study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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 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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Biological: CD19 CAR-T cells
Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Phase I:Cytokine Release Syndrome (CRS)
The incidence and severity of Cytokine Release Syndrome (CRS)
Time frame: 28 days post infusion
Phase I：Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)
The incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)
Time frame: 28 days post infusion
Phase II: Efficacy:Objective response rate (ORR)
Proportions of subjects achieving Autoimmune Diseases response
Time frame: 3 months and 6 months post infusion
AUCS of CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 6 months
Time frame: Up to 6 months post infusion
CMAX of CD19 CAR T cells [Cell dynamics]
CMAX is defined as the highest concentration of CD19 CAR T cells expanded in peripheral blood
Time frame: Up to 6 months post infusion
TMAX of CD19 CAR T cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Time frame: Up to 6 months post infusion
CAR-T proliferation [Cell dynamics]
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Time frame: Up to 6 months post infusion
Pharmacodynamics of CD19 CAR T cells
IL-6 levels measured by Chemiluminescence method
Time frame: Up to 6 months post infusion
B cell levels in peripheral blood
The change of B cell levels in peripheral blood after infusion
Time frame: Up to 6 months post infusion
SLE:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)
The Change of Systemic Lupus Erythematosus Diseases Activity Index, (SLEDAI-2k) from baseline. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) helped standardize outcome measures in SLE and is a clinical tool predominantly used in research to track disease activity and response to therapy. SLEDAI score (obtained by adding the individual 24 item scores) ranges from 0 to 105, where the higher the score, the greater the degree of disease activity. No Flare (Disease no active): 0-3 Mild or moderate flare ( Mild or moderate Active): 4-12 Severe Flare (Severe Active): ≥ 13
Time frame: Up to 6 months post infusion
IIM:Remission Rate
Per the International Myositis Assessment and Clinical Studies Group (IMACS) criteria, complete remission is defined as normalization of all activity measures with no new symptoms, whereas partial remission is defined as improvement of ≥50 % of the baseline abnormal measures.
Time frame: Up to 6 months post infusion
SSc:modified Rodnan Skin Score (mRSS)
Skin improvement will be assessed using the modified Rodnan Skin Score (mRSS). A clinically significant improvement is defined as a ≥5-point absolute decrease or a ≥25 % relative reduction from baseline; stability is defined as a change of ≤3 points.
Time frame: Up to 6 months post infusion
SSc: Pulmonary fibrosis progression
Pulmonary fibrosis progression is defined as a ≥10 % decline in percent-predicted FVC and/or a ≥15 % decline in percent-predicted DLCO, or evidence of progressive fibrosis on high-resolution chest CT.
Time frame: Up to 6 months post infusion
Pemphigus:Pemphigus Disease Area Index (PDAI).
Disease activity will be assessed with the Pemphigus Disease Area Index (PDAI). * Complete remission: PDAI = 0 and no new blisters. * Partial remission: ≥ 75 % reduction in PDAI from baseline. * Treatment failure: \< 50 % reduction in PDAI from baseline or appearance of new blisters.
Time frame: Up to 6 months post infusion
Psoriasis:Psoriasis Area and Severity Index (PASI)
In accordance with the 2023 Chinese Guidelines for the Diagnosis and Treatment of Psoriasis, treatment response will be evaluated using the Psoriasis Area and Severity Index (PASI) * Complete clearance: 100 % improvement in PASI. * Almost complete clearance: 90 - 100 % improvement in PASI. * Effective response: 75 - 90 % improvement in PASI. * Treatment failure: ≤ 50 % improvement in PASI.
Time frame: Up to 6 months post infusion
RA:IIM:Remission Rate
Rheumatoid arthritis: Response will be assessed using ACR, EULAR, SDAI, and CDAI criteria, with the goal of achieving disease remission or a response at least equivalent/superior to that afforded by conventional therapy.
Time frame: Up to 6 months post infusion
ANCA-associated vasculitis/nephritis:Birmingham Vasculitis Activity Score (BVAS)
ANCA-associated vasculitis/nephritis: According to the 2024 KDIGO Clinical Practice Guideline for the Management of ANCA-Associated Vasculitis, disease outcomes will be evaluated with the Birmingham Vasculitis Activity Score (BVAS). Remission is defined as the absence of active vasculitis and glomerulonephritis (BVAS = 0), and relapse is defined as renewed disease activity after partial or complete remission.
Time frame: Up to 6 months post infusion
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Aug 2027, 22 months later.
How these figures are worked out, and which studies are left out of them.
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Hebei Senlang Biotechnology Inc., Ltd. →