To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.
Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment. For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion
Shandong Province
Shandong, Shandong, China
ORR
With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
Time frame: At least half a year
PFS
In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases
Time frame: one year
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