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Recruiting NCT06783816

A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors

Trial Parameters

Condition Acute Lymphocytic Leukemia
Sponsor Shanxi Bethune Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 45
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2023-12-01
Completion 2028-06-01
Interventions
chimeric antigen receptor gene modified T cells

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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):

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