CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
NCT ID: NCT03064269
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2017-03-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. ALT/ AST 《 3x normal
3. Creatinine 《 3x normal
4. Age:10-60.
5. Signed informed consent
Exclusion Criteria
2. Uncontrolled active infection
3. Pregnancy or breast-feeding women
4. Survival less than four weeks
10 Years
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Sheng-Li Xue, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
Other Identifiers
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UnicarTherapy
Identifier Type: -
Identifier Source: org_study_id