NCT05768529

Clinical Study of U16 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Single-arm, Open and Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of U16 Injection in the Treatment of Refractory/Recurrent B-cell Non-Hodgkin's Lymphoma (r/r B-NHL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is a Phase I/II, single-arm, open-label clinical trial, and its primary objective of phase I and phase II is to evaluate the safety and efficacy of U16 Injection in the treatment of relapsed or refractory NHL,respectively.

Conditions

• Relapsed or Refractory Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	U16	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered before U16 treatment.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2023-03-14
• Last updated: 2023-09-21

Locations

2 sites across 1 country: China