B-cell Acute Lymphocytic Leukemia
Conditions
Keywords
CNS B cell acute lymphocytic leukemia
Brief summary
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
Detailed description
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
Interventions
BIOLOGICALCD19 CAR-T cells
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
Sponsors
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia 2. ALT/ AST 《 3x normal 3. Creatinine 《 3x normal 4. Age:10-60. 5. Signed informed consent
Exclusion criteria
1. Active hepatitis B , hepatitis C or HIV infection 2. Uncontrolled active infection 3. Pregnancy or breast-feeding women 4. Survival less than four weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The complete remission (CR) rate | Participants will be followed for the duration of the treatment, an expected average of 12 months | The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined |
Countries
China
Contacts
Primary ContactSheng-Li Xue, MD
Backup ContactLei Yu, Ph.D
Outcome results
None listed