NCT06106893 A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus
| NCT ID | NCT06106893 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2025-12 |
Trial Parameters
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Brief Summary
The purpose of the study is to explore the safety and efficacy of CD19 Universal CAR-γδT cells in active severe systemic lupus erythematosus.
Eligibility Criteria
Inclusion Criteria: 1. Participants or their guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance; 2. Age range from 18 to 70 years old, regardless of gender; 3. Body weight ≥ 40kg; 4. Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form; 5. active SLE needs to meet the following criteria at screening: SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points; 6. Have received at least 8 weeks of standardized treatment for SLE prior to screening; 7. Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study. Exclusion Criteria: 1. Known hypersensitivity to prednisone, immunosuppressive agents; 2. Diagnosis of active severe lupus
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