CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Phase 1
Recruiting
- Conditions
- B-cell Acute Lymphocytic Leukemia
- Interventions
- Biological: CD19 CAR-T cells
- Registration Number
- NCT03064269
- Lead Sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- ALT/ AST 《 3x normal
- Creatinine 《 3x normal
- Age:10-60.
- Signed informed consent
Exclusion Criteria
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Pregnancy or breast-feeding women
- Survival less than four weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 CD19 CAR-T cells CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China