Status:
RECRUITING
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Lead Sponsor:
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Conditions:
B-cell Acute Lymphoblastic Leukemia
Lymphoblastic B-Cell Lymphoma
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
Brief 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.
Detailed Description
Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05333302
Start Date
October 26 2020
End Date
June 1 2025
Last Update
August 28 2024
Active Locations (1)
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1
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus, 223053