refractory / relapsed B cell Acute Lymphocyte Leukemia
Conditions
Interventions
experimental group:non-viral genome targeting anti-CD19 chimeric antigen receptor T cells
Sponsors
Shaanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. ?18 years old and ?75 years old; 2. Signed informed consent (informed consent signed by the legal guardian of the child patient or the incapacitated person) 3. The estimated survival time is ? 3 months; 4. Indication: Flow cytometry to detect CD19 positive B cell malignant hematopathy with positive expression cells accounting for more than 80% of tumor cells; Unsuitable or unconditional for allogeneic hematopoietic stem cell transplantation; Recurrent refractory B-cell malignancies; Patients who relapse after autologous hematopoietic stem cell transplantation. 5. Organ function: Cardiac function: left ventricular ejection fraction > 40% in the last month (echocardiography); Liver function: Alanine aminotransferase and aspartate aminotransferase 92%; 6. Karnofsky scores ? 60; 7. ECOG scores ? 2; 8. Drug usage: No systemic chemotherapy within 1 month; No other immunotherapy within 3 month.
Exclusion criteria
Exclusion criteria: 1. Also suffering from other organ malignant tumors (those who need treatment); 2. Active heart diseases: A history of uncontrolled or symptomatic angina; Myocardial infarction less than 6 months before enrollment; A history of arrhythmias requiring medical treatment or with severe clinical symptoms; Uncontrolled or symptomatic congestive psychological failure( > NYHA level 2); 3. Active injection (HBVDNA or HCVRNA tested positive); 4. AIDS patients or Patients with immunodeficiency from any cause; 5. Patients with grade 3 to 4 acute GvHD had a recurrence after allogeneic hematopoietic stem cell transplantation 6. Tumor cells infiltrated into the central nervous system, tumor cells were detected in the cerebrospinal fluid or tumor was detected by cranial imaging; 7. Epilepsy, dementia or other psychiatric conditions requiring medication inability to understand or follow the study protocol; 8. Substance abuse,medical psychological or social status that may interfere with a subject's participation in the study or assessment of study results; 9. Pregnancy or lactation; 10. After pretreatment, patients still have high white blood cells > 5.0 x 10^9/L or the researchers judge rapid progression of the disease; 11. The researchers concludes that the group was unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate;overall response rate;Incidence and grade of cytokine release syndrome;Incidence and grade of CART related encephalopathy syndrome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of continuous remission;event-free survival;adverse event;overall survival; | — |
Countries
China
Contacts
Public ContactWang yi
Shaanxi Provincial People's Hospital
Outcome results
None listed