Actively Recruiting
An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new cell therapy called QT-219C, a universal allogeneic CAR-T cell product targeting both CD19 and BCMA, for patients with refractory B-cell-related autoimmune diseases such as systemic lupus erythematosus, multi-drug resistant nephrotic syndrome, IgA nephropathy, systemic sclerosis, and ANCA-associated vasculitis. This Phase 1, exploratory, open-label study aims to assess the safety, tolerability, and preliminary effectiveness of QT-219C, focusing on dose-limiting toxicities and clinical responses, with two phases: dose escalation and dose expansion. Participants will undergo a lymphodepleting conditioning regimen before receiving a single intravenous infusion of QT-219C cells. The dose-escalation phase uses a standard 3+3 design to find the recommended dose and observe toxicities. After infusion, subjects are monitored intensively for side effects like cytokine release syndrome and neurotoxicity. Key efficacy assessments occur at Days 28, 60, 90, and 180, followed by a long-term follow-up phase with visits every three months for up to two years. Throughout the study, participants will have baseline labs and imaging, safety monitoring, and evaluations of pharmacokinetics and pharmacodynamics, including CAR-T cell expansion and B-cell depletion. Researchers will track immune responses and disease activity and assess safety over time. The total involvement includes initial screening, treatment, close safety monitoring for 28 days, periodic efficacy checks up to six months, and long-term follow-up for up to two years.
CONDITIONS
Brief Title
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Major organ function must meet specific criteria for bone marrow, liver, kidney, heart, and lung function, with some exceptions for autoimmune-related abnormalities
- Women of childbearing potential must use medically acceptable contraception or abstain during treatment and for 12 months after
- Written informed consent must be provided by participant and guardian if minor
- Disease-specific criteria for systemic lupus erythematosus (age 5 years), meeting classification criteria and treatment failure or intolerance
- Disease-specific criteria for multi-drug resistant nephrotic syndrome (age 3 years), with specific treatment history and biopsy results
- Disease-specific criteria for IgA nephropathy (age 5 years), biopsy confirmed and specific treatment and proteinuria conditions
- Disease-specific criteria for systemic sclerosis (age 5 years), meeting classification criteria, antibody positivity, skin score, and treatment failure
- Disease-specific criteria for refractory or relapsed ANCA-associated vasculitis (age 5 years), meeting diagnostic and activity score criteria, with refractory or severe disease
- Absence of macrophage activation syndrome or CNS lupus symptoms requiring intervention within defined timeframes
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to trial medications
- Grade III or IV heart failure or significant cardiac conditions including recent myocardial infarction or severe arrhythmias
- Uncontrollable or active infection requiring systemic treatment
- Active pulmonary tuberculosis at screening
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus beyond normal reference ranges
- History of severe herpes infections or recent herpes/varicella-zoster virus infections
- Active central nervous system disease
- Presence of malignant tumors
- Secondary or congenital immunodeficiency
- History of major medical conditions preventing QT-219C administration, except lupus
- Recent organ or stem cell transplantation or acute graft-versus-host disease
- Recent live vaccine administration
- Positive pregnancy test
- Participation in other clinical trials with interventions within 3 months
- Clinically significant abnormal laboratory tests preventing study participation
- Any other condition increasing risk or interfering with study outcomes as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive a lymphodepletion regimen before the CAR-T cell infusion.
Daily visits for 3 days
Duration - 1 day
Participants receive a single intravenous infusion of QT-219C, a universal allogeneic CAR-T cell product targeting CD19 and BCMA.
1 infusion visit (in-person)
Duration - 28 days
Participants are closely monitored for 28 days post-infusion to assess dose-limiting toxicities and other safety outcomes.
Frequent visits during the first 28 days post-infusion
Duration - 6 months
Participants undergo evaluations for safety and efficacy at Days 28, 60, 90, and 180 post-infusion.
4 visits at Days 28, 60, 90, and 180 (in-person)
Duration - Up to 2 years
Participants enter a long-term follow-up phase with visits every 3 months for up to 2 years or as clinically indicated to monitor long-term safety and outcomes.
Quarterly visits for up to 2 years
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
Q
Qiuyu Li, MD
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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