A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL
A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL
• 1\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
• 2\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:
‣ No CR after standard chemotherapy;
⁃ The first induction reaches CR, but CR ≤ 12 months;
⁃ Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;
• c.Multiple recurrences.
• 3\. CD5 expression rate was \>90%;
• 4\. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);
• 5\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
• 6\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
• 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
• 8.Estimated life expectancy of minimum of 12 weeks;
• 9.ECOG 0-2;
• 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
• 11\. Those who voluntarily participated in this trial and provided informed consent;