Actively Recruiting
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .
CONDITIONS
Official Title
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Major organ function meets specified criteria for bone marrow, liver, kidney, heart, and lung function (exceptions allowed for autoimmune disease activity).
- Women of childbearing potential must use contraception or abstain during treatment and for 12 months after.
- Written informed consent obtained from participant or guardian.
- Diagnosis of SLE with age 5 years and meeting classification criteria plus specified treatment failure or disease activity levels.
- Diagnosis of multi-drug resistant steroid-resistant nephrotic syndrome (SRNS) with age 3 years and meeting treatment failure or intolerance criteria.
- Diagnosis of IgA nephropathy confirmed by biopsy with age 5 years and meeting treatment or proteinuria criteria.
- Diagnosis of systemic sclerosis with age 5 years, meeting classification criteria and skin score 15, plus treatment failure or intolerance criteria.
- Diagnosis of refractory or relapsed ANCA-associated vasculitis with age 5 years, meeting diagnostic and disease activity criteria, including refractory or severe disease definitions.
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to cyclophosphamide or tocilizumab.
- Grade III or IV heart failure.
- Recent history (within 6 months) of congenital heart disease, acute myocardial infarction, severe arrhythmias, or unstable vital signs.
- Uncontrollable or active infection requiring systemic treatment.
- Active pulmonary tuberculosis at screening.
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with high viral loads.
- History of severe herpes infection or recent herpes/varicella-zoster virus infection within 12 weeks.
- Active central nervous system disease.
- History of malignant tumors before screening.
- Secondary or congenital immunodeficiency.
- Major medical conditions preventing administration of QT-019B except lupus.
- Recent solid organ or stem cell transplantation within 3 months or acute GVHD grade 2 or above within 2 weeks.
- Receipt of live vaccine within 4 weeks before screening.
- Positive blood pregnancy test.
- Participation in other clinical trials with interventions within 3 months.
- Clinically significant abnormal laboratory test results.
- Any other condition judged by investigators to increase risk or interfere with study outcomes.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
J
Jianhua Mao
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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