CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 31, 2024
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
- Biological: CD19 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
Arms, Groups and Cohorts
- Experimental: Arm 1
- CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
Clinical Trial Outcome Measures
Primary Measures
- The complete remission (CR) rate
- Time Frame: 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 10 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Collaborator
- The First Affiliated Hospital of Soochow University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Sheng-Li Xue, Ph.D, Principal Investigator, The First Affiliated Hospital of Soochow University
- Overall Contact(s)
- Sheng-Li Xue, MD, 86-13328008851, slxue@suda.edu.cn
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