Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
Recruiting now · Phase 1
Conditions studied: B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05333302
- Run by
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
- People needed
- 10
- Starts
- 2020-10-26
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-08-28
Who can join
Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk, Minsk Oblast, Belarus (enrolling)
Full record on ClinicalTrials.gov
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