Actively Recruiting
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
Led by Beijing GoBroad Hospital · Updated on 2026-03-03
45
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.
CONDITIONS
Official Title
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 10 to 65 years
- Diagnosis of refractory lupus nephritis, systemic sclerosis, or primary Sjogren syndrome with pulmonary artery hypertension
- For lupus nephritis: failure to achieve remission after 3 to 6 months of immunosuppressive treatment, positive ANA or anti-dsDNA antibodies, and confirmed active lupus nephritis by biopsy
- For systemic sclerosis: classification score of 9 or higher with specific skin thickening
- For pSS-PAH: diagnosis confirmed by right heart catheterization and meeting PAH criteria
- Lymphocyte count >0.5x10^9/L and no contraindications for cell collection
- ECOG performance status 0-2
- Expected survival of at least 90 days
- Ability to understand and sign informed consent
- Stable doses of glucocorticoids and immunosuppressants as specified
- Female patients of childbearing potential must have negative pregnancy test and agree to contraception during and for 1 year after treatment
You will not qualify if you...
- Intracranial hypertension or altered consciousness
- Symptomatic heart failure or severe arrhythmia
- Severe respiratory failure symptoms
- Active or uncontrolled infections including septicemia and tuberculosis
- Other active malignancies
- Diffuse intravascular coagulation
- Uncontrolled diabetes or other endocrine diseases
- Severe mental disorders
- Active intracranial lesions on MRI
- Prior organ transplantation except bone marrow transplant
- Positive pregnancy test in reproductive-aged females
- Positive screening for hepatitis B or C, HIV, or syphilis
- Inability to undergo blood cell collection
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m^2
- Active skin diseases interfering with lupus assessment
- Prior CAR-T therapies other than CD19-CART
- For systemic sclerosis: other connective tissue diseases or similar conditions
- Dialysis dependence or creatinine clearance below 30 ml/min
- Pregnancy or breastfeeding
- Recent major surgery deemed unsuitable for enrollment
- For pSS-PAH: other causes of pulmonary hypertension such as portal hypertension or congenital heart disease
- Severe pulmonary diseases reducing lung function below specified thresholds
- Active infections or uncontrolled systemic diseases as described above
- Positive viral or syphilis tests as above
- Prior CAR-T therapies except CD19-CART
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
北京高博医院
Beijing, China,Beijing, China, 102200
Actively Recruiting
Research Team
Z
ZHOU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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