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Tests treatment safety and results for Autoimmune Diseases
Official title Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07246096
What this study is testing
What is anti-CD19/BCMA U CAR T cells?
anti-CD19/BCMA U CAR T cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for autoimmune diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Common
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- The functions of critical organs meet the following requirements: a )Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L; b) Liver function: ALT ≤ 3 x...
- Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE...
- people had a modified SLEDAI-2K score of ≥8 at screening;
You likely can't join if
- people who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study. Common...
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine...
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
- people with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy...
- people s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
- people with congenital immunoglobulin deficiency;
See the full eligibility criteria
Who can join
- Common
- Age: ≥ 18 years old and ≤ 70 years old, male or female;
- The functions of critical organs meet the following requirements: a )Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L; b) Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN; c) Coagulation function...
- Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE classification criteria, the 2012 Systemic Lupus International Collaborating...
- people had a modified SLEDAI-2K score of ≥8 at screening;
- Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score at screening;
- Based on the results of the central laboratory tests at screening, the subject meets one of the following: a. ANA by immunofluorescence ≥ 1:80 b. Anti-dsDNA antibodies above the normal level c. Anti-Smith antibodies...
- Meets 2013 ACR classification criteria for systemic sclerosis;
- If combined with interstitial pneumonia, interstitial changes suggestive of ground-glass exudates on chest HRCT and FVC or DLCO \<70% predictive value on pulmonary function tests;
- Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg/Kg/d) and cyclophosphamide, as well as any of the following...
- methotrexate, leflunomide, cyclophosphamide, azathioprine, mertiomate, tacrolimus, cyclosporine, and biologics, including rituximab, belimumab and tetracycline;
- Definition of progressiveness; 1) Definition of cutaneous progression: increase in mRSS \>10%; 2) Definition of lung disease progression: 10% decrease in FVC or 5% decrease in FVC with 15% decrease in DLCO (OMERACT...
- Meets 2002 AECG criteria or 2016 ACR/EULAR classification criteria for primary dry syndrome (pSS);
- Definition of disease activity: investigator-assessed disease ESSDAI score of 5 or higher;
- Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg/Kg/d) and cyclophosphamide, as well as any of the following...
- Meets the diagnostic criteria of the 2010 ACR/EULAR classification. Diagnosis of moderately or severely active rheumatoid arthritis with a previous diagnosis of rheumatoid arthritis ≥ 6 months;
- A swollen joint count of ≥ 6 (based on 66 joint counts) and a tender joint count of ≥ 6 (based on 68 joint counts) during the Screening Period;
- C-reactive protein (CRP) ≥ 10 mg/L or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h during the Screening Period;
- EULAR definition of refractory rheumatoid arthritis: 1） Failure of treatment according to EULAR recommended guidelines and failure of treatment with ≥2 b/tsDMARDs despite failure of treatment with csDMARDs. (i) unless...
- Meets 2022 ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatous polyangiitis;
- Positive ANCA related antibodies (MPO-ANCA or PR3-ANCA positive);
- The Birmingham Vasculitis Activity Scale (BVAS) is ≥ 15 points (a total score of 63 points), indicating the activity of the vasculitis condition;
- Glomerular filtration rate (eGFR, CKD-EPI formula) ≥15 ml/min/1.73 m2 during the screening period.
What rules you out
- people who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study. Common exclusion Criteria:
- people with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or people with a history of severe allergic reactions;
- Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
- people with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous...
- people s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
- people with congenital immunoglobulin deficiency;
- people with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease free for more than 5 years);
- people with end-stage renal failure;
- people with positive hepatitis B surface antigen (HBsAg) or hepatitis,B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus...
- people with mental illness and severe cognitive impairment;
- people who have received other clinical trial treatment within 6 months;
- Pregnant or intending to conceive women;
- people with hypertension or diabetes that cannot be controlled by medication;
- In the opinion of the investigator, there are other reasons that prevent some people from being included in this study. Specific exclusion Criteria: Relapsed/Refractory Systemic lupus erythematosus
- Except for SLE, any clinically significant history of cardiac, endocrine, blood, liver, immune, metabolic, urinary, pulmonary, neurological, skin, psychiatric, or renal disorders, or other major diseases that may...
- Except for SLE, any active skin disease that could interfere with the research evaluation of SLE including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous lupus manifestations (such...
- Combined cirrhosis of the liver;
- Combination of aplastic anemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disease (MPD). Relapsed/Refractory rheumatoid arthritis 1\. Functional status of rheumatoid arthritis graded at level 4...
- Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2;
- If the patient has alveolar hemorrhage invasive lung ventilation is required, estimated to last longer than the screening period.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.