NCT07093073

Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma

A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.

Detailed description

The primary objective of this study is to evaluate the efficacy and safety of CD19-targeted CAR-T cells engineered with an IL-6 silencing element in patients with relapsed or refractory B-cell lymphoma.

Conditions

• B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ssCART-19	Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.

Timeline

• Start date: 2025-01-23
• Primary completion: 2027-01-31
• Completion: 2029-01-31
• First posted: 2025-07-30
• Last updated: 2025-09-19

Locations

3 sites across 1 country: China