The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Dose CAR+ cells/kg B-cell lymphoma 4×10\^6 Acute lymphocytic leukemia 2×10\^6 Chronic lymphocytic leukemia 10×10\^6
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, China
Overall response rate
Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
Time frame: 12 weeks
Overall Survival
from the time of enrollment to death from any cause or the date of the last follow-up visit
Time frame: 6 months,1 year, 2 years
Progression-free Survival
the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit
Time frame: 12 weeks,6 months,1 year, 2 years
Event-free Survival
the time from enrollment to any events, or the date of the last follow-up visit
Time frame: 12 weeks,6 months,1 year, 2 years
Dose-limiting toxicity (DLT)
Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of XLCART001 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to ≤grade 2 within 14 days, transient (\<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever.
Time frame: 28 days
Number of CAR-T cells
The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Time frame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
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Duration of CAR-T cells
The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Time frame: Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years