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

NCT05333302 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-28

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

CD19 CAR-T-cells

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

DRUG

Tocilizumab

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

Sponsors & Collaborators

  • Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

    lead OTHER

Principal Investigators

  • Olga Aleinikova, MD, Prof · Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Belarus

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333302 on ClinicalTrials.gov