rr DLBCL
Conditions
Interventions
DL1:Infusion of 100×10^6?CAR+ cell
DL2:Infusion of 300×10^6?CAR+ cell
DL3:Infusion of 600×10^6?CAR+ cell
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3 months; 4. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): a) CR not achieved after 2 lines of standardized chemotherapy; b) and or relapse after CR. 5. Recent therapy ended (including radiation therapy, chemotherapy, monoclonal antibody or other related therapies) beyond 4 weeks; 6. No active infection; 7. Not participated other interventionary clinical trials in the past 3 months; 8. ECOG <= 2; 9. Patients or their legal guardians understand this trail 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. Sever lung dis-function history; 3. With other type of malignancy; 4. Sever 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; 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. Women patients with pregnancy or in breast feeding period; 13. Other conditions or situations which principal investigator believes that would increase subjects risk or may interference the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;complete remission, CR/CR with incomplete count recovery, CRi;Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactLiu Li
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed