Actively Recruiting
An Exploratory Study Evaluating Safety and Efficacy of Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA for B Cell-Related Autoimmune Diseases
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and preliminary effectiveness of QT-219CX, a universal allogeneic CAR-T cell therapy targeting CD19 and BCMA, in 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. The study includes an exploratory phase focusing on dose escalation and expansion, designed to identify safe dosage levels and monitor potential toxicities. Participants receive a lymphodepleting conditioning treatment followed by a single intravenous infusion of QT-219CX cells. The research consists of two phases: a dose-escalation phase using a standard "3+3" design to determine dose-limiting toxicities and a dose-expansion phase to further assess safety and response. Following infusion, subjects undergo close monitoring for adverse effects and clinical responses. Throughout the study, participants will be evaluated through laboratory tests, imaging, and clinical assessments at multiple time points including days 28, 60, 90, and 180, with key efficacy assessments at days 90 and 180. Safety monitoring includes watching for cytokine release syndrome, neurotoxicity, graft-versus-host disease, infections, and viral reactivation. Long-term follow-up occurs every three months for up to two years to observe pharmacokinetics, pharmacodynamics, and overall safety, ensuring comprehensive evaluation of treatment impact.
CONDITIONS
Brief 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 defined criteria for bone marrow, liver, kidney, heart, and lung function, with some exceptions for autoimmune-related abnormalities
- Women of childbearing potential must use contraception or abstain during treatment and for 12 months after
- Written informed consent provided by participant or guardian
- Diagnosis of systemic lupus erythematosus (age 5 years) meeting specific classification and treatment resistance criteria
- Diagnosis of multi-drug resistant nephrotic syndrome (age 3 years) meeting treatment response criteria
- Diagnosis of IgA nephropathy (age 5 years) confirmed by biopsy and meeting treatment criteria
- Diagnosis of systemic sclerosis (age 5 years) meeting classification criteria and treatment resistance
- Diagnosis of refractory or relapsed ANCA-associated vasculitis (age 5 years) meeting activity and treatment criteria
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to trial medications
- Grade III or IV heart failure or serious heart conditions
- Uncontrolled or active infections including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus
- History of severe herpes infections or recent herpes/varicella-zoster virus infection
- Active central nervous system disease
- History of malignant tumors
- Secondary or congenital immunodeficiency
- Significant medical conditions preventing QT-019B administration except lupus
- Recent organ or stem cell transplantation or active graft-versus-host disease
- Receipt of live vaccine within 4 weeks before screening
- Positive pregnancy test
- Participation in other clinical trials with intervention within 3 months
- Clinically significant abnormal laboratory test results
- Any condition increasing risk or interfering with trial outcomes as judged by investigators
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several days prior to infusion
Participants receive a lymphodepletion regimen to prepare for the CAR-T cell infusion.
Multiple visits as needed during conditioning
Duration - Day 0
Participants receive a single intravenous infusion of QT-219CX, 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 any dose-limiting toxicities and adverse events.
Frequent visits during the first 28 days post-infusion
Duration - Up to 6 months
Participants undergo safety and efficacy assessments through Day 180 post-infusion, including monitoring for cytokine release syndrome and immune-related events.
Assessment visits at Days 28, 60, 90, and 180
Duration - Up to 2 years
Participants enter a long-term monitoring phase with visits every 3 months for up to 2 years or as clinically indicated to observe long-term safety and efficacy.
Quarterly visits during long-term follow-up
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
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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