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New treatment option for Relapsed/Refractory Systemic Lupus Erythematosus
Official title Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07361094
What this study is testing
What is Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy?
Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory systemic lupus erythematosus.
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
- Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells. Although many treatments are available, some patients do not respond adequately or experience repeated disease flares despite long-term therapy.
- 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
- Age 18 to 70 years (inclusive), of any sex.
- Patients with failure of prior single-target CD19 or BCMA therapy, with a washout period of at least 6 months since the last treatment.
- Disease-specific criteria for different indications: 3.1 Relapsed/Refractory Moderate-to-Severe Systemic Lupus Erythematosus (SLE) Participants must...
- Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus.
- At screening, positive antinuclear antibody (ANA) (titer ≥1:80), and/or positive anti-dsDNA antibody, and/or positive anti-Sm antibody.
You likely can't join if
- 1\. Prior history of, or concurrent, other active malignancies, including malignancy-associated polymyositis/dermatomyositis. Exceptions include...
- Use of B-cell-depleting therapy within 1 month prior to screening and assessed by the investigator as not having failed therapy, including agents...
- High-dose intravenous human immunoglobulin (IVIG) within 1 month prior to screening.
- Therapeutic-dose systemic corticosteroids within 24 hours prior to lymphodepleting conditioning (prednisone \>20 mg/day or equivalent).
- Corticosteroid pulse therapy within 2 weeks (defined as prednisone ≥500 mg/day or equivalent).
- Telitacicept within 2 weeks prior to screening, or belimumab within 3 weeks prior to screening. 5\. History of severe central nervous system (CNS)...
See the full eligibility criteria
- Age 18 to 70 years (inclusive), of any sex.
- Patients with failure of prior single-target CD19 or BCMA therapy, with a washout period of at least 6 months since the last treatment.
- Disease-specific criteria for different indications: 3.1 Relapsed/Refractory Moderate-to-Severe Systemic Lupus Erythematosus (SLE) Participants must meet all of the following:
- Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus.
- At screening, positive antinuclear antibody (ANA) (titer ≥1:80), and/or positive anti-dsDNA antibody, and/or positive anti-Sm antibody.
- Moderate-to-severe disease activity defined as: SLEDAI-2000 score ≥8 at screening; if hypocomplementemia and/or anti-dsDNA antibody contribute to the score, the clinical SLEDAI-2000 score (excluding low complement...
- A documented history of at least 6 months of stable standard-of-care therapy for SLE prior to screening, with active disease for at least 2 months before screening. Standard therapy includes stable use (alone or in...
- Diagnosis of SSc according to the 2013 EULAR/ACR Classification Criteria for Systemic Sclerosis.
- Diffuse cutaneous SSc as defined by LeRoy et al. (1988), characterized by extensive skin fibrosis involving areas proximal to the elbows and/or knees.
- Presence of interstitial lung disease (ILD) at screening, with forced vital capacity (FVC) 45-70% predicted, or diffusing capacity for carbon monoxide (DLCO) 40-70% predicted.
- Relapsed/refractory disease defined as inadequate response to prior standard therapy or relapse after remission. Standard therapy includes glucocorticoids, cyclophosphamide, and at least one immunosuppressive or...
- Evidence of active disease, defined by at least one of the following: (a) progressive skin involvement at screening with an increase in modified Rodnan skin score (mRSS) ≥10% within the past 6 months; (b) evidence of...
- Diagnosis of SS according to the 2016 EULAR/ACR Classification Criteria for Sjögren's Syndrome.
- Positive anti-Ro/SSA antibody at screening.
- Salivary flow rate at screening: stimulated whole salivary flow ≥0.05 mL/min, or unstimulated whole salivary flow ≥0.01 mL/min.
- Active disease defined as ESSDAI score ≥5. 3.5 Relapsed/Refractory Autoimmune Hemolytic Anemia (AIHA) Participants must meet all of the following: (1) Diagnosis consistent with the Chinese Guidelines for the Diagnosis...
- 1\. Prior history of, or concurrent, other active malignancies, including malignancy-associated polymyositis/dermatomyositis. Exceptions include cervical carcinoma in situ, noninvasive basal cell or squamous cell skin...
- Use of B-cell-depleting therapy within 1 month prior to screening and assessed by the investigator as not having failed therapy, including agents targeting CD19, CD20, CD22, CD52, CD38, or BCMA (monoclonal antibodies or...
- High-dose intravenous human immunoglobulin (IVIG) within 1 month prior to screening.
- Therapeutic-dose systemic corticosteroids within 24 hours prior to lymphodepleting conditioning (prednisone \>20 mg/day or equivalent).
- Corticosteroid pulse therapy within 2 weeks (defined as prednisone ≥500 mg/day or equivalent).
- Telitacicept within 2 weeks prior to screening, or belimumab within 3 weeks prior to screening. 5\. History of severe central nervous system (CNS) disease or related symptoms within the past 6 months (simple trigeminal...
- Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, or coronary/peripheral artery bypass surgery.
- Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); congenital long QT syndrome; left anterior fascicular block (bifascicular block)...
- Uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy. 14\. History of other autoimmune diseases...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.