RecruitingPhase 1NCT05625594

Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/Mem T-lymphocytes) for the Treatment of Central Nervous System Lymphoma

A Phase 1 Study to Evaluate Intracerebroventricular (ICV) Administration of CD19-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With CNS Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized type of immune cell therapy called CAR T cells — engineered immune cells that are trained to target and kill lymphoma cells — delivered directly into the fluid surrounding the brain and spinal cord. It is designed for people with central nervous system lymphoma (lymphoma that has spread to or originated in the brain) that has not responded to prior treatments. **You may be eligible if...** - You are 18 or older with confirmed CNS lymphoma (primary or secondary) that has come back or not responded to prior treatment - Your cancer expresses the CD19 protein on its surface (especially if you have had prior CD19-targeted therapy) - You have tried and failed or cannot tolerate standard CNS-directed therapies - Your general health and organ function are adequate **You may NOT be eligible if...** - You have active, uncontrolled infection - You cannot tolerate the required procedures - You have certain organ function problems that would make treatment unsafe - You are pregnant or breastfeeding 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

PROCEDUREAspiration

Undergo CSF aspiration

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDURECatheterization

Undergo catheterization

BIOLOGICALCD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem T-lymphocytes

Given ICV

PROCEDUREComputed Tomography

Undergo CT

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET


Locations(1)

City of Hope Medical Center

Duarte, California, United States

View Full Details on ClinicalTrials.gov

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NCT05625594


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