Actively Recruiting

Phase 1
Age: 1Year - 30Years
All Genders
NCT05333302

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

Led by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · Updated on 2024-08-28

10

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • CD19+ relapsed or refractory lymphoblastic leukemia or lymphoma
  • Karnofsky or Lansky performance scale score of 70 or higher
  • Peripheral blood T-cell count greater than 150 cells/µL
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Primary immunodeficiencies or genetic syndromes
  • Neurologic diseases
  • Autoimmune diseases or polyallergies
  • Transfusion of donor lymphocytes less than 6 weeks before CAR-T cell infusion
  • Graft-versus-host disease grade 2 to 4
  • Uncontrolled systemic infection
  • Hypoxia with oxygen saturation below 90%
  • Severe liver dysfunction with ALT or AST levels 3 times or more above age normal limits
  • Renal dysfunction with serum creatinine 3 times or more above age normal limits
  • Positive serology for HIV, active hepatitis B or C
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, Belarus, 223053

Actively Recruiting

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Research Team

E

Elena Lukoyko, MD

CONTACT

A

Aleksandr Meleshko, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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