RecruitingPhase 2NCT04661020

CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma


Sponsor

Zhejiang University

Enrollment

40 participants

Start Date

Dec 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether CD19 CAR-T cell therapy — a type of genetically engineered immune cell treatment — can work as a first-line option for people with newly diagnosed aggressive B-cell lymphoma who are unwilling to receive standard RCHOP chemotherapy. **You may be eligible if...** - You are 18 or older with newly diagnosed aggressive B-cell lymphoma (such as DLBCL or high-grade B-cell lymphoma) - You are unwilling to receive standard RCHOP chemotherapy but are willing to receive a short pre-conditioning drug regimen instead - After two courses of pre-conditioning therapy, your cancer showed partial response or stable disease on PET-CT - Your heart, liver, and kidney function are within acceptable ranges - Your ECOG performance status is 0–2 **You may NOT be eligible if...** - You have a history of brain injury, stroke, epilepsy, or serious heart rhythm problems - You have active hepatitis B, hepatitis C, or HIV - You have previously received any CAR-T or genetically modified T-cell therapy - 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

DRUGCD19 CAR-T cells

Each subject receive CD19 CAR T-cells by intravenous infusion


Locations(1)

The First Affiliated Hospital,College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT04661020


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