NCT06313957

A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.

Detailed description

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.

Conditions

• Relapsed B-cell Non-Hodgkin Lymphoma
• Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	LUCAR-20SP cells	Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2024-03-15
• Last updated: 2025-03-25

Locations

3 sites across 1 country: China