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.
The main objective is to evaluate the safety and efficacy of a novel CAR-T therapy that co expresses IL-15 in malignant hematological tumors. The secondary objective is to investigate the in vivo survival time of the novel CAR-T co expressing IL-15 and the activation and proliferation of a novel CAR-T co expressing IL-15 in vivo.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The rate of intravenous infusion of CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\~30 mL normal saline.
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITINGmonitor the survival time of CAR-T in vivo
The survival of CAR-T in vivo will be monitored periodically by flow cytometry after CAR T reinfusion.
Time frame: 6 months
Record antitumor effects after reinfusion of CAR-T
Determine partial response (PR) or complete response (CR) for subjects with active disease. In view of the small number of subjects, remission should be recorded in detail; For subjects treated with minimal residual lesion (MRD), MRD clearance results were recorded.
Time frame: 28 days
Disease-free survival
DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit.
Time frame: 3 years
Overall Survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up
Time frame: 3 years
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