RecruitingNot ApplicableNCT06513429

IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)

Clinical Study on Evaluating the Efficacy and Safety of IM19 CAR-T Cell Therapy in Patients With Refractory Systemic Lupus Erythematosus

Sponsor

Peking University Third Hospital

Enrollment

6 participants

Start Date

Jul 30, 2024

Study Type

INTERVENTIONAL

Conditions

Refractory Systemic Lupus Erythematosus

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called IM19 CAR-T cells for people with refractory systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 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. to {"Not Applicable"}.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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