To evaluate the CR rate of B-NHL subjects who achieved PR at intermediate assessment after first-line chemotherapy treated with autologous stem cell transplantation + Anti-CD19 CAR T cells.
At present, the incidence of malignant hematological diseases represented by leukemia, lymphoma and multiple myeloma is increasing year by year, ranking in the top ten of tumor incidence and mortality, which greatly endangers people's health and social development . B-cell non-Hodgkin's lymphoma (NHL) is a common aggressive malignant lymphoma. Poor response of some patients to traditional first-line chemotherapy is one of the major problems facing this disease. As a result, researchers are using emerging tools such as high-throughput sequencing to further understand the nature of the disease, refine the classification of the disease, and on this basis develop personalized treatments to improve the prognosis of the disease. Lymphoma has a complex immunosuppressive microenvironment that may prevent CAR T from achieving sustained precision tumor killing. As a revolutionary immunotherapy strategy, CAR-T therapy is currently faced with some bottleneck problems such as post-treatment relapse (including antigen loss relapse and antigen positive relapse), CAR-T consumption, off-target effect and so on. At present, autologous stem cell transplantation still plays a pivotal role in high-risk B-NHL. But at the same time, autologous stem cell transplantation is also faced with the age of patients, the influence of minimal residual disease (MRD) status before transplantation, chemotherapy dependence sensitivity, post-transplantation recurrence, post-transplantation granulosis infection and other problems. In this study, we explored the efficacy and safety of autologous stem cell transplantation combined with Anti-CD19 CAR-T cells in the treatment of B-cell NHL in patients with B-NHL who achieved partial response (PR) in the interim assessment after 3-4 courses of first-line therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d\*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was \> 2\*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGComplete response rate
Proportion of enrolled patients who achieved complete response after treatment
Time frame: From 3 months to 1 year.
overall survival
The time interval between patient infusion of CAR-T and death from any cause or the end of follow-up.
Time frame: From 3 months to 1 year.
Progression-free survival
The time between treatment and observation of disease progression or death from any cause.
Time frame: From 3 months to 1 year.
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