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Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus
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.
Details
| Lead sponsor | Chongqing Precision Biotech Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 18 |
| Start date | 2026-01 |
| Completion | 2028-08 |
Conditions
- Systemic Lupus Erythematosus
Interventions
- CD19 CAR-T cells
Primary outcomes
- 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.
Countries
China