IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)
Trial Parameters
Brief Summary
The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg or 1×10\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.
Eligibility Criteria
Inclusion Criteria: * 1)The subject was diagnosed with systemic lupus erythematosus and met the classification criteria of EULAR/ACR 2019 SLE (see Annex 2) * 2\) Age ≥ 18 years old, ≤ 65 years old * 3\) Weight ≥ 40 kg * 4\) Meets the current clinical standards for refractory systemic lupus erythematosus: the disease remains active or relapses and progresses after systemic treatment using the current standard treatment regimen, including steroids (sufficient or shock therapy), immunosuppressants (cyclophosphamide or mycophenolate mofetil), and biologics (belizumab or Rituximab) * 5\) Currently, one or more of the following stable dose standard therapies are being used to treat SLE: steroids, antimalarial drugs, immunosuppressants. If the subject is receiving steroids, the following conditions must be met: at screening time and during screening period, the maximum dose of steroids is 30mg/day prednisone (or equivalent dose). Before screening, the dose of steroids should remain stable for