RecruitingPhase 1NCT05333302

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

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


Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Enrollment

10 participants

Start Date

Oct 26, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing CAR-T cell therapy — a type of immunotherapy using genetically engineered immune cells — in children and young adults with CD19-positive relapsed or refractory leukemia or lymphoma (cancer that came back or didn't respond to prior treatment). **You may be eligible if...** - You have CD19-positive leukemia or lymphoma that has relapsed or not responded to prior treatment - You have sufficient T-cells in your blood (above 150 cells/µL) - Your performance score is 70 or above (able to carry out normal activities with some effort) **You may NOT be eligible if...** - You have a primary immune deficiency or genetic syndrome - You have a neurological disease or autoimmune disease - You have an uncontrolled active infection - You have active graft-versus-host disease (grade 2–4) - You have significant liver or kidney dysfunction - You are HIV positive, have active Hepatitis B or C, or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19 CAR-T-cells

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

DRUGTocilizumab

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


Locations(1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, Belarus

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NCT05333302


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