Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
• Age≥15 years and ≤80years，female and male；
• CD30+ lymphocyte malignancies;
• CD30 expression \>10% by immunohistochemistry；
• At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;
• Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;
• Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;
• The estimated survival time ≥3 months;
• ECOG performance status 0-2，KPS\>60%;
• Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\<34 μmol/L；creatinine clearance rate\>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；
• ALC ≥0.5×109/L，PLT\>30×109/L，Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation;
• MRI showed no central involvement of lymphoma;
• Patients with fertility must be willing to be able to use reliable contraceptive measures ;
• The subject or legal guardian can understand and voluntarily sign the written informed consent.