Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimeric antigen receptor (CAR-ITNK cells) is a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of CAR-ITNK cells infusions in patients with relapsed and refractory B cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CAR-ITNK cells will be infused over 10-15 minutes on Day 0.
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGAdverse Events
Time frame: 12 months
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time frame: 3 months
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time frame: 6 months
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time frame: 12 months
OS
overall survival
Time frame: 1 year
DFS
disease-free survival
Time frame: 1 year
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