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

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Status and phase

Enrolling

Phase 1

Conditions

Lymphoblastic B-Cell Lymphoma

B-cell Acute Lymphoblastic Leukemia

Treatments

Biological: CD19 CAR-T-cells

Drug: Tocilizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT05333302

CD19CAR-T_LL_children

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

1 to 30 years old

Volunteers

No Healthy Volunteers

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.