Actively Recruiting
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-04-02
15
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C 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-219C .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
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 years or older
- Adequate bone marrow function: ANC �3 1.0 x 10^9/L, hemoglobin �3 60 g/L, platelet count �3 30 x 10^9/L
- Adequate liver function: ALT �3 3 times ULN (except inflammatory myopathy), AST �3 3 times ULN, total bilirubin �3 2.0 times ULN (up to 3.0 for Gilbert syndrome)
- Adequate renal function: eGFR �3 30 mL/min/1.73 m^2 (exceptions possible with informed consent)
- Adequate cardiac function: LVEF �3 55% and no significant structural abnormalities
- Adequate pulmonary function: SpO2 �3 92%, no severe pulmonary disease
- Women of childbearing potential must use contraception or abstain during treatment and for 12 months after
- Written informed consent obtained from participant or guardian
- Disease-specific criteria for SLE, MDR-SRNS, IgA nephropathy, systemic sclerosis, and ANCA-associated vasculitis as detailed in the protocol, including age �3 5 years for most diseases, disease activity, treatment history, and diagnostic confirmation
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to study medications including cyclophosphamide or tocilizumab
- Grade III or IV heart failure (NYHA)
- Recent acute myocardial infarction, congenital heart disease, severe arrhythmias, or unstable vital signs requiring treatment
- Uncontrollable or active infection requiring systemic treatment
- Active pulmonary tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with viral loads above normal
- History of severe herpes infections or recent herpes/varicella-zoster virus infections
- Active central nervous system disease
- Malignant tumors prior to screening
- Secondary or congenital immunodeficiency
- Major medical conditions preventing QT-219C administration except lupus
- Recent organ or stem cell transplantation or recent acute graft-versus-host disease
- Recent live vaccine within 4 weeks
- Positive pregnancy test
- Participation in other clinical trials with interventions within 3 months
- Any clinically significant abnormal laboratory results or conditions increasing risk or interfering with the study as judged by investigators
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
J 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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