A Multicenter, Single Arm, Open Label Clinical Study on the Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors
The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.
• I (or the authorized representative/legal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research procedures;
• Histopathological or flow cytometric diagnosis of CD19 and/or CD22, BCMA-positive hematological malignancies;
⁃ ≥15 years old, ≤80 years old;
• If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation;
• Estimated survival ≥12 weeks;
• Good heart, liver and kidney function:
• Serum creatinine ≤ 1.5 mg/dL (1mg/dl=88.4umol/L); Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg/dl (1mg/dl=17.1umol/L):
• Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:
• Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;
• Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.
‣ If the answer to any of the above is \"no\", the subject will not be allowed to participate in this study.