Lupus NephritisNCT06277427
Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells
A study testing PRG-1801 （CAR-T against BCMA） in people with Lupus Nephritis and ANCA Associated Vasculitis, run by Lingli Dong at 1 site in China.
Trial summary
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis, ANCA Associated Vasculitis
- What is being tested?
- PRG-1801 （CAR-T against BCMA）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- Absolute lymphocyte count: ≥ 0.5 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
- Absolute neutrophil count: ≥ 1.0 × 10 ^ 9/L [The use of granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects are not allowed to receive this supportive treatment within 7 days before the screening period laboratory examination];
- Platelets: Subject platelet count ≥ 50 × 10 ^ 9/L (subjects are not allowed to receive blood transfusion support within 7 days before the screening period laboratory examination);
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- Hemoglobin: ≥ 8.0 g/dL (allowing the use of recombinant human erythropoietin) [subjects have not received red blood cell (RBC) infusion within 7 days prior to the screening period laboratory examination];
- Creatinine clearance rate: (CrCl) or glomerular filtration rate (GFR) (Cockcroft Gault formula) ≥ 30 mL/min;
- Total bilirubin (serum): Total bilirubin (serum) ≤ 1.5 × ULN; Blood bilirubin>1.5 × Gilbert subjects from ULN can be enrolled with the consent of the sponsor
- AST and ALT: ≤ 3.0 × ULN;
- Plasma prothrombin time (PT), international standardized ratio (INR), partial prothrombin time (APTT): PT ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN, INR ≤ 1.5 × ULN
- Willing to sign an informed consent form.
- - for refractory ANCA-associated vasculitis
- ①According to the 2022ACR/EULAR criteria, diagnosed with AAV (GPA or MPA subtype), who has not achieved remission (BVAS score of 0) for ≥ 3 months after receiving standardized treatment. Severe patients who have previously undergone standardized treatment to induce remission and are now relapsing after maintenance therapy; ②The patient is currently or has a positive ANCA during the course of the disease; ③Severe illness (severe organ involvement or life-threatening) requiring treatment (BVAS score ≥ 3.0); The definition of severe illness is vasculitis with life-threatening or organ manifestations.
- - for refractory LN
- According to the 2019 American Society of Rheumatology (ACR) criteria, diagnosed with systemic lupus erythematosus, within 6 months prior to infusion, confirmed by renal tissue biopsy according to the 2003 International Society of Nephrology (ISN)/Society of Nephropathology (RPS) criteria as active, proliferative lupus nephritis (LN), type III or IV [excluding III (C), IV S (C), and IV G (C)], or type III/IV combined with type V, And have received standard treatment that is ineffective or relapses after disease remission. ②Positive anti-nuclear antibodies (ANA) and/or anti-dsDNA antibodies during the screening period. ③The SLE Disease Activity Index (SLEDAI-2000) score during the screening period is ≥ 8. SLEDAI-2000 clinical score ≥ 6 points, but low complement and/or anti ds-DNA positivity can be selected. ④The estimated survival period is at least 3 months.
Who cannot join
- -Subjects who meet any of the following criteria should be excluded from this study:
- Pregnant or lactating women;
- If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;
- Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch Schönlein), rheumatoid arthritis, inflammatory myositis, anti-glomerular basement membrane disease, or cryoglobulinemia vasculitis;
- Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus enteritis, and lupus crisis; Other autoimmune diseases other than combined SLE, including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc;
- Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of PRG-1801 or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab, albumin), or have experienced severe allergic reactions in the past;
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- A history of malignant tumors within 5 years (① subjects with cervical carcinoma in situ who have been completely removed and have not experienced recurrence or metastasis for at least 3 years may participate in this study. ② subjects with basal cell or squamous cell carcinoma who have been completely removed and have not experienced recurrence for at least 3 years may participate in this study);
- Obvious evidence of cardiovascular disease as follows: a N-terminal B-type natriuretic peptide (NT proBNP)>8500ng/L; b. The New York Heart Association (NYHA) classifies heart failure as Grade IV; c. Patients who received hospitalization for unstable angina or myocardial infarction within 6 months prior to the first administration, or patients who received percutaneous cardiac intervention and received the most recent stent placement within 6 months or coronary artery bypass grafting within 6 months;
- Received the following medication treatment within the prescribed time before single collection: ① Received B cell depletion therapy such as rituximab within 24 weeks; ② Received biological agents (such as TNF) within 4 weeks or 2 half-lives - Treatment with inhibitors, interleukin receptor inhibitors, belizumab, and tamoxifen; ③ Received treatment such as immunosuppressants within 2 weeks or 5 half-lives ; ④ If systemic glucocorticoids need to be used for a long time from 2 weeks before single collection to the study period, the dose of the hormone should not exceed 10mg/day; ⑤ Received plasma exchange or immunosorbent therapy within 24 weeks, and received intravenous immunoglobulin (IVIG) therapy within 4 weeks.
- Vaccinate with live/attenuated vaccines within 4 weeks prior to single collection or during the study period;
- Chronic and active hepatitis B ( the HBV DNA test is higher than 500IU/ml), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, or syphilis infection;
- There is an active infection that requires intravenous injection of antibiotics or hospitalization treatment;
- Major surgery or surgical treatment caused by any reason within 4 weeks prior to enrollment;
- Any serious and/or uncontrollable comorbidities that the researcher believes may interfere with the evaluation during the research process;
- Participated in other intervention clinical trials within 3 months prior to enrollment or within 5 drug half-lives (whichever is longer);
- Other conditions determined by the researcher as unsuitable for lymphocyte clearance or cell infusion, or other unsuitable patients for study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Lingli Dong, MD, 86-27-83665519, tjhdongll@163.com
Cong Ye, MD, 86-27-83665518, Yecong@163.com
About this study
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.
- Conditions
- Lupus Nephritis, ANCA Associated Vasculitis
- Being tested
- PRG-1801 （CAR-T against BCMA）
- Keywords
- CAR-T, Lupus nephritis, ANCA associated vasculitis, BCMA
- Medical subject headings
- Lupus Nephritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG-1801 （CAR-T against BCMA）Drug
Patients with refractory LN and ANCA-associated vasculitis will be treated with PRG-1801
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment | Experimental | Lymphocyte clearance before PRG-1801 cells' infusion; Plan to design two dose levels (2.5x10^6 CAR-T/kg and 5.0x10^6 CAR-T/kg), with 3-6 AAV and LN subjects included in each dose group, totaling 12-24 subjects. Within each dose group, the next subject can be administered after the previous subject has completed at least 14 days of safety observation.
Dose group 1: with a dosage of 2.5x10^6 (cells/kg) per dose Dose group 2: with a dosage of 5.0x10^6 (cells/kg) per dose Receives: Drug: PRG-1801 （CAR-T against BCMA） |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE Incidence of PRG-1801 Single Infusion
AE Incidence of PRG-1801 Single Infusion
Measured: 24 months after PRG-1801 infusion
Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN.
To evaluate the DLT occurred within 28 days and 3 months after PRG-1801 infusion
Measured: 28 days and 3 months after PRG-1801 infusion
Secondary outcomes (24)
Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion)
The proportion of subjects who maintained remission after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion)
Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.)
Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion)
Changes in SLEDAI-2000 score from baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion )
Changes in FACIT fatigue score from baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion)
Changes in PGA score (0-10) from baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion)
Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion）
Changes in UPCR (g/24h）relative to baseline after cell infusion
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.）
The proportion of subjects who achieved overall response rate after cell infusion.
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.）
The proportion of subjects who achieved complete renal response after cell infusion.
Measured: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
PK feature evaluation (PK parameters related to CAR copy number）
PK parameters related to CAR copy number
Measured: baseline, Day2, Day6, Day10, Day21, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Serum sBCMA level
Serum sBCMA level (count/uL)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum ANCA titer level (AAV)
Serum ANCA titer level (AAV)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum dsDNA level (LN)
Serum dsDNA level (IU/mL)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum ANA titer level (LN)
Serum ANA titer level (IU/mL)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum complement C3 levels
Serum complement C3 levels (g/L)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum complement C4 levels
Serum complement C4 levels (g/L)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum immunoglobulin quantification
Serum immunoglobulin quantification (g/L)
Measured: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Levels of CRP levels
Levels of CRP levels (mg/L)
Measured: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Levels of ferritin levels
Levels of ferritin levels (ug/L)
Measured: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Levels of cytokine levels
Levels of cytokine levels (pg/mL)
Measured: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Changes of peripheral blood lymphocyte subsets
Changes of peripheral blood lymphocyte subsets (count/uL)
Measured: baseline, Day2, Day6, Day10, Day14, Day21, Day28, Month 2, Month 3, Month 6 after cell infusion
Expression levels of BCMA on peripheral blood B cell subsets surface
Expression levels of BCMA on peripheral blood B cell subsets surface (%), using flow cytometer method.
Measured: baseline, through study completion, an average of 2 years
The level of anti drug antibody (ADA)
The level of anti drug antibody (ADA)
Measured: baseline, through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start5 Feb 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingli Dong
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Responsible party
- Sponsor-investigator, Lingli Dong, Tongji Hospital
- Investigators
- Lingli Dong, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277427
- Sponsor's protocol ID
- [2023]S208
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells
- ClinicalTrials.gov ID
- NCT06277427
- Acronym / sponsor ID
- [2023]S208
- Conditions
- Lupus Nephritis, ANCA Associated Vasculitis
- Keywords
- CAR-T, Lupus nephritis, ANCA associated vasculitis, BCMA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Lingli DongUniversity, hospital or other
- Collaborators
- Shenzhen Pregene Biopharma Co., Ltd.
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment | Experimental | Drug: PRG-1801 （CAR-T against BCMA）Lymphocyte clearance before PRG-1801 cells' infusion; Plan to design two dose levels (2.5x10^6 CAR-T/kg and 5.0x10^6 CAR-T/kg), with 3-6 AAV and LN subjects included in each dose group, totaling 12-24 subjects. Within each dose group, the next subject can be administered after the previous subject has completed at least 14 days of safety observation. Dose group 1: with a dosage of 2.5x10^6 (cells/kg) per dose Dose group 2: with a dosage of 5.0x10^6 (cells/kg) per dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years old, not exceeding 70 years old (including 70 years old);
- If the kidneys are involved, estimate the glomerular filtration rate (eGFR) to be ≥ 15 mL/minute/1.73 m2;
- The following test values within 3 days before the collection of mononuclear cells meet the following standards:
- Willing to sign an informed consent form.
- - for refractory ANCA-associated vasculitis
Key exclusion criteria (16 listed)
- Pregnant or lactating women;
- If combined with alveolar hemorrhage, invasive pulmonary ventilation is required;
- Refractory GPA and MPA: Combined with other autoimmune diseases involving multiple organ systems, such as EGPA, SLE, IgA vasculitis (Henoch Schönlein), rheumatoid arthritis, inflammatory myositis, anti-glomerular basement membrane disease, or cryoglobulinemia vasculitis;
- Difficult to treat LN: severe extrarenal clinical manifestations such as lupus encephalopathy, pulmonary hemorrhage, lupus myocarditis, lupus enteritis, and lupus crisis; Other autoimmune diseases other than combined SLE, including dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, etc;
- Individuals who are known to have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of PRG-1801 or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab, albumin), or have experienced severe allergic reactions in the past;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRG-1801 （CAR-T against BCMA）Patients with refractory LN and ANCA-associated vasculitis will be treated with PRG-1801 | Drug | CAR-T treatment |
Primary outcome
AE Incidence of PRG-1801 Single Infusion
Time frame: 24 months after PRG-1801 infusion
AE Incidence of PRG-1801 Single Infusion
Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN.
Time frame: 28 days and 3 months after PRG-1801 infusion
To evaluate the DLT occurred within 28 days and 3 months after PRG-1801 infusion
24 secondary outcomes
Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion )
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion)
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion）
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.）
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.）
Time frame: Month1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
PK feature evaluation (PK parameters related to CAR copy number）
Time frame: baseline, Day2, Day6, Day10, Day21, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 after cell infusion
Serum sBCMA level
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum ANCA titer level (AAV)
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum dsDNA level (LN)
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum ANA titer level (LN)
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum complement C3 levels
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum complement C4 levels
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Serum immunoglobulin quantification
Time frame: baseline, Day14, Day28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24 month after cell infusion
Levels of CRP levels
Time frame: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Levels of ferritin levels
Time frame: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Levels of cytokine levels
Time frame: baseline, Day2, Day6, Day10, Day14, Day21, Day28 after cell infusion
Changes of peripheral blood lymphocyte subsets
Time frame: baseline, Day2, Day6, Day10, Day14, Day21, Day28, Month 2, Month 3, Month 6 after cell infusion
Expression levels of BCMA on peripheral blood B cell subsets surface
Time frame: baseline, through study completion, an average of 2 years
The level of anti drug antibody (ADA)
Time frame: baseline, through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lingli Dong, MD principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRG-1801 （CAR-T against BCMA） in people with Lupus Nephritis and ANCA Associated Vasculitis, run by Lingli Dong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingli Dong, MD (+862783665519, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE Incidence of PRG-1801 Single Infusion (time frame: 24 months after PRG-1801 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.