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A Phase IIIa Clinical Study to Evaluate Universal Allogeneic CAR-T Cells QT-019B Targeting CD19 and BCMA for the Treatment of Refractory Systemic Lupus Erythematosus
Led by Hangzhou Qihan Biotech Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of QT-019B, a dual-target, universal CAR-T cell therapy for adults with refractory systemic lupus erythematosus SLE. This phase IIIa clinical study aims to determine the recommended dose RD and understand how the treatment affects disease activity in patients who have not responded to standard therapies. The study is sponsored by Hangzhou Qihan Biotech Co., Ltd. and plans to enroll between 18 and 24 participants. The study consists of two main phases dose escalation and dose expansion. Initially, participants receive a QT-019B cell injection at Dose A 1106kg, with a 14-day interval between enrollments. If no dose-limiting toxicities DLTs are observed during the observation period, the study may proceed to Dose B 3106kg. If DLTs occur, additional participants may be enrolled at Dose A, or the study dose may be reduced or the study terminated depending on the number of DLTs observed. Participants will be closely monitored through safety assessments including tracking adverse events within 28 days of treatment. Researchers will also evaluate changes in disease activity scores such as the SLEDAI-2000, Physicians Global Assessment, and BILAG-2004 Index over up to two years. Blood samples will be collected to measure the concentration and behavior of QT-019B cells. The overall study involves regular visits, assessments, and follow-up to comprehensively evaluate safety and treatment impact over time.
CONDITIONS
Brief Title
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at screening, any gender
- Diagnosed with systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
- Refractory SLE defined by failure to respond or intolerance to glucocorticoids combined with other immunosuppressive therapies
- Received prior treatment with at least two different non-glucocorticoid immunosuppressive therapies, including at least one B cell-depleting biologic such as belimumab or rituximab (unless contraindicated or unavailable)
- Positive serological test for at least one autoantibody (ANA ≥1:80, anti-dsDNA, anti-Sm, or other disease-related autoantibodies)
- At screening, either SLEDAI-2K score ≥6 for SLE with or without lupus nephritis, or severe refractory SLE-ITP with platelet count <30×10⁹/L or <50×10⁹/L with bleeding tendency
- Adequate organ function excluding SLE-related abnormalities: neutrophil count ≥0.5×10⁹/L, hemoglobin ≥60 g/L, ALT and AST ≤2×ULN, total bilirubin ≤2×ULN, creatinine clearance ≥30 ml/min
- Agree to use approved contraception or abstain during treatment and for 12 months after; females of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Voluntarily consent, comply with study procedures, and agree to follow-up
You will not qualify if you...
- History or presence of central nervous system disorders such as seizures, stroke, severe brain injury, dementia, Parkinson's disease, or mental illness, except stable epilepsy without seizures for 1 year
- Need for hemodialysis or high-dose corticosteroids within 2 months before screening
- Uncontrolled serous cavity effusion causing symptoms after treatment
- Other active autoimmune diseases within 2 years prior to screening except SLE and related conditions
- Hematopoietic dysfunction unrelated to SLE or prior/awaiting stem cell or organ transplantation
- Previous gene-modified cell therapy such as TCR-T, CAR-T, CAR-NK
- Use of other investigational drugs for SLE within 4 weeks before screening
- Positive tests for active hepatitis B or C, HIV, or syphilis infections
- Uncontrolled hypertension or serious cardiovascular diseases posing significant risks
- Recent symptomatic deep vein thrombosis, pulmonary embolism, or significant oxygen desaturation
- History of malignancy within 5 years except certain low-risk cancers
- Active infections requiring systemic antimicrobial therapy within 30 days
- Any other condition the investigator believes poses risk or could affect study adherence or results
Research Team
Z
Zhijiang Wang
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