B-cell Acute Lymphocytic Leukemia Clinical Trial
Official title:
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou |
Lead Sponsor | Collaborator |
---|---|
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | The First Affiliated Hospital of Soochow University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The complete remission (CR) rate | The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined | Participants will be followed for the duration of the treatment, an expected average of 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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