B cell acute lymphoblastic leukemia/NHL
Conditions
Interventions
Case series:CD19-sepecific chimeric antigen receptor T cells (BG-T19)
Sponsors
Pediatrics of Nanfang hospital
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 18 years; 2. Relapsed or refractory B-precursor ALL and NHL defined as one of the following: (1) Primary refractory disease; (2) Relapsed or refractory disease after first or later salvage therapy; 3. Relapsed or refractory disease after allogeneic transplant and meet the following criteria: (1) Subject has stopped taking immunosuppressive agents or will not require immunosuppressive therapy; (2) Successful T-cell expansion (>80% CD3+ cells after 10 days ex vivo expansion); 4. Adequate renal function: serum/plasma creatinine 1?10 G/L; 7. HIV, hepatitis B and hepatitis C negative; 8. Subject has stopped chemotherapy for at least 5 times the metabolic half-life since the last dose at the time of assent or consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of active clinically significant CNS dysfunction; 2. History of cancer or has other form of cancer at the time of assent or consent; 3. Performance status>2; 4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled; 5. Under systemic hormone therapy (exclude aerosol hormone therapy) at the time of assent or consent; 6. Allergic to any components of the intervention and associated adjuvants; 7. Known infection with HIV, hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive); 8. Other conditions in the opinion of investigators that affect the subjects compliancy to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Free Survival;Safety; | — |
Countries
China
Contacts
Public ContactDing Wen
Guangzhou Bio-gene Technology Co., Ltd
Outcome results
None listed