This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.
Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGNumber of participants with adverse events
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Time frame: 5 years
One-month remission rate
Response of B-ALL to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015).
Time frame: 1 month
Overall survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored).
Time frame: 5 years
Event-free survival
EFS 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 (censored).
Time frame: 5 years
Relapse-free survival
RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored).
Time frame: 5 years
Rate of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells
In vivo (bone marrow and peripheral blood) rate of CAR-T cells were determined by means of flow cytometry.
Time frame: 5 years
Quantity of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells
In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry.
Time frame: 5 years
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Quantity of anti-CD19 CAR copies in bone marrow cells and peripheral blood cells
In vivo (bone marrow and peripheral blood) quantity of anti-CD19 CAR copies were determined by means of qPCR.
Time frame: 5 years