NCT06503211

On the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Lymphoma

Phase I Clinical Study on the Safety, Tolerability, and Efficacy of UTAA09 Injection in the Treatment of Recurrent or Refractory B-cell Non Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main research objective is to evaluate the safety, tolerability, and pharmacokinetic characteristics of UTAA09 cell preparation in the treatment of relapsed/refractory B-cell non Hodgkin's lymphoma patients. The secondary research objective is to explore the clinical efficacy of UTAA09 injection after administration and to explore the content of CD19 positive B cells in peripheral blood after UTAA09 injection administration.

Detailed description

Single dose, single arm trial, exploring the initial 28 day safety and efficacy of the investigational drug.

Conditions

• Recurrent or Refractory B-cell Non Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	UTAA09 injection	The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into 3 x 108\~1 x 1010 CD19-CAR - γδT cells.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: China