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NCT Number: NCT05333302

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

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.

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Key information

Conditions

B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoblastic B-Cell Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

1 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, 223053, Belarus

Location status: Recruiting

Location contact

Elena Lukoyko, MD

CONTACT

+37529 1643075

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CD19 CAR-T-cells

Biological

One dose of CD19 CAR-T cells (1*10e6 CAR+ T-cells/kg) by intravenous infusion.

Tocilizumab

Drug

Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).

Other names: Actemra

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 1 month

    Adverse events will be graded according to the CTCAE v5.0

Secondary outcomes

  1. Objective Response Rate (ORR) (CR+CRi+CRm)

    Time frame: 28 days after CAR-T cells infusion

    The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), complete molecular remission (CRm).

  2. Overall survival (OS)

    Time frame: 1 year

    The proportion of patients with overall survival

  3. Events free survival (EFS)

    Time frame: 1 year

    Time from CAR-T cells infusion to CR failure, relapse, or death.

  4. Leukemia free survival (LFS)

    Time frame: 1 year

    Time from achievement of CR/CRi/CRm to the time of relapse, death in remission, or last follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksandr Meleshko, PhD

CONTACT

[email protected]

+375296940023

Elena Lukoyko, MD

CONTACT

[email protected]

+375291643075

Sponsors and collaborators

Lead sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Other

Registry information

Official study title

Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 18, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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