RecruitingPhase 1NCT05333302
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Sponsor
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Enrollment
10 participants
Start Date
Oct 26, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Eligibility
Min Age: 1 YearMax Age: 30 Years
Inclusion Criteria4
- CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
- Karnofsky or Lansky performance scale greater or equal to 70;
- T-cells count in peripheral blood \>150 cells/µL;
- Written informed consent.
Exclusion Criteria11
- primary immunodeficiencies or genetic syndromes;
- 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.
Interventions
BIOLOGICALCD19 CAR-T-cells
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
DRUGTocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05333302
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