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Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma

RECRUITINGPhase 1Sponsored by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Actively Recruiting
PhasePhase 1
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology
Started2020-10-26
Est. completion2024-12
Eligibility
Age1 Year – 30 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05333302

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

Age: 1 Year – 30 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions3

B-cell Acute Lymphoblastic LeukemiaCancerLymphoblastic B-Cell Lymphoma

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