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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    10
  • sponsor
    Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Updated on 1 May 2022

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.

Description

Locally manufactured second generation autologous CD19 CAR-T cells are used for immunotherapy. Protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one CAR-T cells intravenous infusion with tocilizumab premedication.

Details
Condition B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
Treatment Tocilizumab, CD19 CAR-T-cells
Clinical Study IdentifierNCT05333302
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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