RecruitingPhase 1Phase 2NCT04186520

CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies


Sponsor

Medical College of Wisconsin

Enrollment

100 participants

Start Date

May 18, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of genetically engineered immune cell therapy — called CAR T cells — that simultaneously targets two proteins (CD19 and CD20) on B-cell lymphomas. It is designed for patients whose lymphoma has come back or stopped responding to other treatments. **You may be eligible if...** - You are 18–80 years old - You have been diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (cancer has returned or is not responding) - Your cancer expresses CD19 and/or CD20 proteins (confirmed by standard testing) - You have adequate immune cell counts (CD3 count ≥50 cells/mm³) - Your cancer has not spread to the brain or spinal fluid **You may NOT be eligible if...** - You have active brain or spinal cord involvement by lymphoma - You have serious uncontrolled infections - You have severe organ dysfunction - 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

BIOLOGICAL8/12-Day Production of Car-T Cells

A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

BIOLOGICAL8/12-Day Production of Cryopreserved Car-T Cells

A fixed cryopreserved dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

BIOLOGICAL12-Day Production of Car-T Cells

A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.


Locations(1)

Medical College of Wisconsin and Froedtert Hospital

Milwaukee, Wisconsin, United States

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NCT04186520


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