Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
NCT ID: NCT05333302
Last Updated: 2024-08-28
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
2020-10-26
2025-06-30
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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CD19 CAR-T cells immunotherapy
After a cycle of lymphodepleting chemotherapy a patient receive locally produced autologous CD19 CAR-T cells
CD19 CAR-T-cells
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Tocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Interventions
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CD19 CAR-T-cells
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Tocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky or Lansky performance scale greater or equal to 70;
* T-cells count in peripheral blood \>150 cells/µL;
* Written informed consent.
Exclusion Criteria
* neurologic diseases;
* autoimmune diseases or polyallergie;
* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
* GvHD grade 2-4;
* uncontrolled systemic infection;
* hypoxia (Sp02\<90%)
* severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age;
* renal dysfunction: serum creatinine level \>=3x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
* pregnancy.
1 Year
30 Years
ALL
No
Sponsors
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Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
OTHER
Responsible Party
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Principal Investigators
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Olga Aleinikova, MD, Prof
Role: STUDY_DIRECTOR
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Locations
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Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus
Countries
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Central Contacts
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Facility Contacts
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Elena Lukoyko, MD
Role: primary
Other Identifiers
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CD19CAR-T_LL_children
Identifier Type: -
Identifier Source: org_study_id
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