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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Criteria

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.