Actively Recruiting
Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-12-01
36
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.
CONDITIONS
Official Title
Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients or their legal guardians must acknowledge the risks and procedures involved and provide informed consent.
- Predicted survival time of at least 12 weeks.
- ECOG performance status between 0 and 2.
- Left ventricular ejection fraction (LVEF) of 55% or higher.
- Renal function with eGFR of 30 mL/min/1.73 m2 or higher (exceptions considered by investigators).
- Liver enzymes AST and ALT less than or equal to 3 times the upper limit of normal; total bilirubin less than or equal to 2 times the upper limit of normal.
- No serious lung lesions; oxygen saturation (SpO2) of 92% or higher.
- Negative pregnancy test for females of childbearing age and agreement to use effective contraception for one year after infusion.
- For SLE patients: at least 5 years old, diagnosed by 2019 criteria, moderate to severe disease despite multiple treatments or intolerance, SLEDAI 2K score over 6, no recent CNS disease or macrophage activation syndrome.
- For MDR-SRNS patients: at least 3 years old, diagnosed by 2021 KDIGO guidelines, not responding to standard treatments or relapse, confirmed kidney pathology.
- For IgA nephropathy patients: at least 5 years old, biopsy-confirmed diagnosis, treated with ACE inhibitors or ARBs for at least three months, meeting specific treatment response or intolerance criteria, excluding secondary causes and uncontrolled blood pressure.
You will not qualify if you...
- Severe allergic reactions or hypersensitivity to study medications.
- Uncontrolled or active infections requiring systemic treatment within one week prior to screening.
- Grade III or IV heart failure.
- Recent congenital heart disease, heart attack, severe arrhythmias, serious myocarditis, or unstable vital signs needing hypertensive drugs.
- Renal replacement therapy within three months prior to treatment.
- Positive tests for hepatitis B or C, HIV, syphilis, or cytomegalovirus with active infection.
- Recent herpes or varicella-zoster virus infections within 12 weeks.
- History of seizures or active central nervous system disease.
- Current or past malignant tumors or other life-threatening diseases.
- Secondary or congenital immunodeficiency.
- Significant medical conditions preventing study treatment, except lupus.
- Recent organ or stem cell transplantation or acute graft-versus-host disease.
- Receipt of live vaccines within four weeks before screening.
- B cell-targeted drug therapy within one month before enrollment.
- Positive pregnancy test.
- Participation in other clinical studies within three months prior.
- Clinically significant abnormal laboratory results preventing participation.
- Any condition judged by investigators to increase risk or interfere with the study outcomes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
J
Jianhua Mao, PhD
CONTACT
Q
Qiuyu Li, MD
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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