NCT05607420

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cellectis S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Conditions

• B-cell Non-Hodgkin Lymphoma (B-NHL)

Interventions

Type	Name	Description
BIOLOGICAL	UCART20x22	Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
BIOLOGICAL	CLLS52	A monoclonal antibody that recognizes a CD52 antigen

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2022-11-07
• Last updated: 2025-08-24

Locations

10 sites across 3 countries: United States, France, Spain

Regulatory

• FDA-regulated drug study