RecruitingPhase 1NCT06875063

GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL

The Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of GB5005 Chimeric Antigen Receptor T-cell Injection in Treating Patients With CD19-positive Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL).

Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

45 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma Refractory Lymphoma Chimeric Antigen Receptor T-cell

Summary

To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called GB5005 — where immune cells are engineered to target a protein called CD19 on cancer cells — for people with non-Hodgkin lymphoma that has returned or is no longer responding to standard treatments. **You may be eligible if...** - You are 18 to 70 years old - You have been diagnosed with non-Hodgkin lymphoma confirmed by lab tests - Your cancer cells test positive for CD19 - Your cancer has come back or stopped responding after at least two rounds of treatment, including a stem cell transplant if eligible **You may NOT be eligible if...** - You have uncontrolled infections - You have severe organ problems - You are pregnant or breastfeeding - You have received prior CD19-targeted CAR-T 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

DRUGGB5005 CART

Included patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min.