NCT07456371

PIC1 Injection Therapy for Relapsed/Refractory B-NHL

Clinical Study of PIC1 Injection for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed/refractory B-cell Non-Hodgkin Lymphoma.

Detailed description

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo generated Chimeric Antigen Receptor T-cell (CAR-T) therapy in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma. Upon enrollment, subjects will receive an intravenous infusion of PIC1 injection designed for in vivo CAR-T generation. Following infusion, subjects will be hospitalized for observation and evaluated for safety and efficacy. Subjects will be followed for up to 2 years to assess long-term disease control.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	PIC1 Injection	Three dose groups (1.0×10\^9 TU, 2.0×10\^9 TU, 4.0×10\^9 TU) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2029-02-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: China