RecruitingEarly Phase 1NCT07093411

Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-E9D,LUCAR-E9K, a Dual-targeted Cell Product Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma


Sponsor

Beijing GoBroad Hospital

Enrollment

48 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy that targets two proteins at once — CD19 and CD20 — in people with B-cell non-Hodgkin lymphoma (a type of blood cancer) that has come back or not responded to initial treatment. This dual-targeting approach may help the therapy be more effective even if cancer cells lose one of the two targets. **You may be eligible if...** - You are aged 18 to 75 years old - You have confirmed B-cell non-Hodgkin lymphoma that expresses CD19 and/or CD20 - Your cancer did not respond to first-line treatment, or it came back within 12 months of achieving complete remission - You are not suitable for, or not willing to receive, standard CAR-T cell therapy - You are in good general health (ECOG 0 or 1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have another active invasive cancer - You have active graft-versus-host disease (a complication after bone marrow transplant) or need immune-suppressing treatment for it - Your lymphoma has actively spread to the brain or spinal fluid - You have significant bleeding problems or are taking long-term steroids or immune suppressants - You are 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

BIOLOGICALLUCAR-E9D or LUCAR-E9K cells product

Prior to infusion of the LUCAR-E9D or LUCAR-E9K cells product subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine


Locations(3)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

View Full Details on ClinicalTrials.gov

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NCT07093411