Actively Recruiting
Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
Led by Beijing GoBroad Hospital · Updated on 2026-03-03
45
Participants Needed
1
Research Sites
93 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 umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.
CONDITIONS
Official Title
Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with refractory lupus nephritis confirmed by biopsy within 6 months
- Male or female patients aged 3-65 years
- Systemic lupus erythematosus meeting 2019 ACR/EULAR criteria
- Positive anti-nuclear antibody test (ANA titer 60 1:80) or positive anti-dsDNA serum antibody test
- B cell CD19+ expression and stopped immunosuppressive agents for more than 1 week
- No severe allergic constitution
- ECOG physical condition score 0-2
- Expected survival of at least 90 days
- Ability and willingness to sign informed consent
- Patients aged 6-65 years with systemic sclerosis per 2013 ACR/EULAR classification criteria
- Patients aged 18-65 years with primary Sjogren's syndrome and pulmonary hypertension diagnosed by right heart catheterization
- Stable dose of corticosteroids and immunosuppressants as specified before treatment
- Negative pregnancy test for women of childbearing age and agreement to use contraception during study
- Appropriate organ function including liver enzymes and oxygen saturation above 95% without oxygen
You will not qualify if you...
- Intracranial hypertension, severe heart failure, severe respiratory failure, or malignancies
- Diffuse intravascular coagulation or uncontrolled infections
- Uncontrolled diabetes or serious mental disorders
- Head MRI showing significant skull lesions
- Previous organ transplantation (except bone marrow)
- Positive pregnancy test or breastfeeding
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Estimated glomerular filtration rate (eGFR) below 30 ml/min/1.73m2
- Active skin diseases interfering with lupus evaluation
- Previous CAR T cell therapy other than CD19-CAR T
- Pulmonary hypertension due to other causes than primary Sjogren's syndrome
- Severe active central nervous system lupus requiring recent therapy
- Dialysis or creatinine clearance below 30 ml/min
- Recent major surgeries unsuitable for inclusion
- Overlapping connective tissue diseases or similar conditions explaining symptoms
- Pregnancy or breastfeeding
- Active infections such as sepsis, bacteremia, mycosis, or tuberculosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
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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