autologous hematopoietic stem cell transplantation combined with car-t cells in the treatment of refractory and relapsed malignant lymphoma

Conditions: Lymphoma

Summary: clinical study on the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with car-t cells in the treatment of refractory and relapsed malignant lymphoma

current studies have shown that under standard treatment, patients with large masses and high-grade dlbcl have a poor prognosis. data from major centers around the world on car-t cell treatment of relapsed and refractory b-cell nhl show that car-t treatment of relapsed and refractory b-cell nhl has a low complete remission rate but a low recurrence rate after remission.therefore, new treatment options are urgently needed to achieve long-term relief. cd19 car-t therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory mm patient at the university of pennsylvania, and good research progress has been made. craig s et al. studied the safety and effectiveness of cd19 car-t cell therapy after high-dose chemotherapy and autologous stem cell transplantation hdt-asct. the object of the study was relapsed and refractory non-hodgkin's lymphoma, with 2-year progression-free survival ( pfs) is 30%. therefore, autologous hematopoietic stem cell transplantation combined with car-t cell therapy is expected to improve the complete remission rate and long-term survival rate. in summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with car-t cells for the treatment of refractory and relapsed non-hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: * 1.male or female, 18-75 years old (including the threshold value); 2. according to the 2016 who classification criteria for lymphocytic tumors, histologically confirmed include: dlbcl (nos); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed dlbcl, and pmbcl and high-grade b-cell lymphoma subject. 3.r/r b-nhl (conform one of the following conditions) 1. the subject did not remission or relapsed after receiving second-line or higher-line chemotherapy 2. primary resistance 3. the subject relapsed after receiving autologous hematopoietic stem cell transplantation exclusion criteria: * subjects with any of the following exclusion criteria were not eligible for this trial: 1. history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; 3. pregnant (or lactating) women; 4. patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. active infection of hepatitis b virus or hepatitis c virus; 6. those who have used any gene therapy products before. 7. the proiferation rate is less than 5 times response to cd3/cd28 co-stimulation signal; 8. serum creatinine \> 2.5mg/dl or alt / ast \> 3 times uln or bilirubin \> 2.0mg/dl; 9. those who suffer from other uncontrolled diseases are not suitable to join the study; 10. hiv infection; 11. any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Keywords: asct cd19 car-t