B-cell leukemia B-cell leukemia CAR-CD19 T cell
Conditions
Interventions
s weight (kg)
4. Four million cells/recipient'
s weight (kg)
Mononuclear cells will be harvested from allogeneic donor simultaneously stem cell harvest for hematopoietic stem cell transplantation. T lymphocytes in harvested cell will be activated,
Experimental Biological/Vaccine
CAR-CD19 T cell infusion
CAR-CD19 T cells will be administered into the enrolled patients according to 4 tiers
1. Five hundred thousand cells/recipient'
s weight (kg)
2. One million cells/recipient'
s weight (kg)
3. Two million cells/recipient'
Sponsors
TCELS
Faculty of Medicine Ramathibodi Hospital,
Mahidol University
Eligibility
Sex/Gender
All
Age
1 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Age less than 25 years 2. Treated at Ramathibodi Hospital 3. Diagnosed with relapsed/refractory B-cell leukemia with expressing CD19 4. Bilirubin less than 4.5mg/dL 5. AST less than 150 U/dL 6. Glomerular filtration rate 50 or more than 50ml/1.73m2/min 7. Available stem cell donor in family members 8. No pregnancy 9. Signed informed consent
Exclusion criteria
Exclusion criteria: Denied to be enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantity of CAR-CD19 T cell 12 months cell/kg | — |
Secondary
| Measure | Time frame |
|---|---|
| event free rate 1 year cases | — |
Countries
Thailand
Contacts
Public ContactUsanarat Anurathapan
Faculty of Medicine Ramathibodi Hospital
Outcome results
None listed