RecruitingPhase 2NCT06698484

To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)

A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma


Sponsor

National University of Malaysia

Enrollment

20 participants

Start Date

Jun 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)


Eligibility

Min Age: 13 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cell therapy where a patient's own immune cells are re-engineered to attack cancer (CAR-T cell therapy) for people with B-cell non-Hodgkin lymphoma (a type of blood cancer) that has returned or not responded to prior treatments. **You may be eligible if...** - You have confirmed CD19-positive B-cell non-Hodgkin lymphoma - Your lymphoma came back within one year after stem cell transplant, OR you are resistant to second-line treatment with no curative options available - You are between 13 and 75 years old - You have adequate kidney and liver function - You have at least one measurable tumor **You may NOT be eligible if...** - You do not have CD19-positive lymphoma - You have significant organ dysfunction (kidney or liver problems) - You have active uncontrolled infections - You have had prior CAR-T cell therapy 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

2×10\^6 CAR T cells/kg


Locations(1)

Universiti Kebangsaan Malaysia

Bandar Tun Razak, Kuala Lumpur, Malaysia

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NCT06698484


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