Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Se
A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabol
| Condition(s) | Systemic Lupus Erythematosus (SLE) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE. |
| Who can participate | Inclusion Criteria: 1. Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months; 2. Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions; 3. No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening; 4. Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal discharge until 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Locations | Wuhan, Hubei, China |
| Start date | 2025-07-11 |
| NCT ID | NCT07031713 |
| Official listing | https://clinicaltrials.gov/study/NCT07031713 |