r/r B-NHL
Conditions
Interventions
DL 1:Infusion 600x10^6 CAR positive cells
Sponsors
Shaanxi Provincial People's Hispital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age>18, 1.5cm, the longest diameter of extranodal focus > 1.0cm; 11. Patients or their legal guardians understand this trial and volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency, LVEF < 50; 2. Severe lung dis-function history; 3. With other types of malignancy; 4. Severe infection which cannot be controlled; 5. With metabolic disorder (except for diabetes); 6. With autoimmune disease or genetic immunodeficiency; 7. Active hepatitis (HBV DNA or HCV RNA positive); 8. HIV infection, EBV infection, HCMV infection; 9. Bio-product-related allergy (including antibiotics); 10. With grade 34 acute GvHD history or patients with GvHD after stem cell transplantation; 11. CNS tumor cell evidence; 12. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement; 13. Women patients with pregnancy or in the breastfeeding period; 14. Other conditions or situations that the principal investigator believes would increase subjects' risk or may interfere the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission, CR/CR with incomplete count recovery, CRi;Objective Response Rate, ORR;overall survival, OS;progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Countries
China
Contacts
Public ContactYi Wang
Shaanxi Provincial People's Hispital
Outcome results
None listed