RecruitingEarly Phase 1NCT04532203

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma


Sponsor

Zhejiang University

Enrollment

72 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies


Eligibility

Min Age: 3 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immune cell therapy called CAR-T cells — where a patient's own immune cells are modified to attack cancer — for blood cancers that have returned or stopped responding to treatment and have spread to the central nervous system (brain and spinal cord). **You may be eligible if...** - You are between 3 and 70 years old - You have been diagnosed with a relapsed or treatment-resistant B-cell leukemia or lymphoma that has spread to the central nervous system - Your leukemia cells carry the CD19 marker on their surface - Prior standard chemotherapy has not worked or your disease has relapsed at least twice **You may NOT be eligible if...** - You have active, uncontrolled infection (including HIV or hepatitis) - You have severe organ dysfunction (heart, liver, kidneys) - You are pregnant or breastfeeding - You have had a prior CAR-T cell therapy that caused severe reactions 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

DRUGCAR-T cells

Each subject receive CAR T-cells by intravenous infusion

PROCEDUREOmmaya Reservoir

Surgical catheter placement into the fourth ventricle of the brain


Locations(1)

The First Affiliated Hospital,College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT04532203


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