NCT06875063

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).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Primary objectives: To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Secondary objectives: To assess the preliminary efficacy of GB5005 in patients with CD19-positive B-NHL; To describe the pharmacokinetic profile of GB5005 and observe its proliferation and persistence in the body; To explore the correlation between the pharmacokinetic characteristics of GB5005 and cytokine release syndrome (CRS) as well as neurological events.

Conditions

• Non-hodgkin Lymphoma
• Refractory Lymphoma
• Chimeric Antigen Receptor T-cell

Interventions

Type	Name	Description
DRUG	GB5005 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.

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2025-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China