Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
Condition(s) studied
Investigational drug(s) / intervention(s)
CD19 CAR-T cells: Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
Study summary
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Eligibility
Primary outcome measure(s)
- The safety of CAR-T cell therapy in patients with refractory SLE [Safety] — 3 months
Types, frequency and severity of adverse events. - The changes from baseline in SLEDAI-2K [efficacy] — 6 months
Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity. - The changes from baseline in PGA [efficacy] — 6 months
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity. - The changes from baseline in BILAG-2004 [efficacy] — 6 months
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved. - The number of patients with SRI-4 response [efficacy] — 3 months
The definition of SRI-4 response: SLEDAI-2K ≥ 4-Point improvement; PGA with no worsening (\<0.3 point increase); BILAG 2004 with no new A domain score and no more than 1 new B domain scores. - The number of patients with LLDAS [efficacy] — 6 months
The definition of LLDAS: SLEDAI-2K ≤ 4 and no disease activity in major organs (kidneys, central nervous system, heart and lungs), and no vasculitis or fever; no new disease activity symptoms were added compared with previous disease assessments; PGA ≤ 1; irrespective of serology; with permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics. - The number of patients with DORIS [efficacy] — 6 months
The definition of DORIS: SLEDAI-2K = 0 ; PGA \< 0.5 ; irrespective of serology; with permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Affiliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | Recruiting |
More Chongqing Precision Biotech Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07331467 on ClinicalTrials.gov ↗ ← All trials in China