To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell He
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
| Condition(s) | 19 and 22+ B Cell Hematologic Tumors, 19 and 20+ B Cell Hematologic Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years). |
| Who can participate | Inclusion Criteria: 1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL); 2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old; 4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception pr |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Hebei Senlang Biotechnology Inc., Ltd. |
| Locations | Wuhan, Hubei, China |
| Start date | 2022-04-08 |
| NCT ID | NCT05388695 |
| Official listing | https://clinicaltrials.gov/study/NCT05388695 |