An Open-label, Dose-escalation Early-phase Clinical Study of CD7-targeted CAR-T Cells for the Treatment of Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
• Age ≥ 18 years old and\<80 years old；
• According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
• Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
• Histologically confirmed as CD7 positive；
• According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
• Blood routine neutrophil count ≥ 1.0×109/L during screening; For individuals without bone marrow invasion, platelet count ≥ 75×109/L, Hb≥80g/L; For individuals with bone marrow invasion, platelet count ≥50×109/L, Hb≥60g/L；
• Creatinine clearance rate\>60ml/min (Cockcroft and Gault formula); serum total bilirubin≤1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range;
• left ventricular Ejection fraction (LVEF) ≥ 50%.
• Estimated survival time of over 3 months.
⁃ ECOG: 0-1.
⁃ Subjects or their Legal guardian voluntarily participate in the trial and sign the informed consent form.