4SCAR19U T Cells Targeting B Cell Malignancies
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistenc
| Condition(s) | B Cell Malignancies |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers. |
| Who can participate | Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell surface expression of CD19. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV or HCV infection. 5. Pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. Prior failed CAR-T treatment. |
| Ages | 6 Months to 75 Years |
| Sex | All |
| Lead sponsor | Shenzhen Geno-Immune Medical Institute |
| Locations | Shenzhen, Guangdong, China |
| Start date | 2023-10-31 |
| NCT ID | NCT05995015 |
| Official listing | https://clinicaltrials.gov/study/NCT05995015 |