CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors

Inclusion Criteria14

• Subjects with a diagnosis of relapsed/refractory hematologic malignancies that meet any of the following criteria:
• Recurrence: peripheral blood or bone marrow blasts (proportion>5%) after achieving complete remission after previous standard treatment regimens, or extramedullary disease, including:
• i) Early recurrence within 12 months; ii) Late recurrence of 12 months or more with no remission after one course of standard induction chemotherapy; iii) Relapse after autologous or allogeneic hematopoietic stem cell transplantation.
• Refractory: complete remission is not achieved after at least two courses of standard induction therapy, or complete remission is not achieved after first-line or above salvage therapy
• At the time of enrollment screening, bone marrow flow cytometry detected tumor cells as CD7 expression and/or pathological immunohistochemistry of extramedullary lesions was confirmed that tumor cells expressed CD7.
• If tumor cells are detected in peripheral blood during enrollment screening, the immunophenotype of tumor cell surface at the time of flow cytometry detection should be CD4 and CD8 negative. If the surface immunophenotype of peripheral blood tumor cells is not CD4 and CD8 negative, the condition of ≤1% proportion of peripheral blood tumor cells must be met.
• Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.
• Expected survival over 3 months;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
• Serum creatinine ≤ 1.5× ULN；
• Left ventricular ejection fraction (LVEF) ≥50%;
• Baseline peripheral oxygen saturation > 90%;
• Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
• Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.