NCT07453446

Clinical Study of U29 Injection (CD30-CART) in Patients With CD30-Positive Relapsed/Refractory Lymphoma

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CD30-targeted Chimeric Antigen Receptor T (CAR-T) Cell Injection in Patients With CD30-positive Relapsed or Refractory Lymphoma

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

Summary

This is a single-center, open-label study conducted in subjects with relapsed or refractory CD30-positive lymphoma, with priority given to Hodgkin lymphoma and anaplastic large cell lymphoma.

Detailed description

The primary purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of CD30-targeted CAR-T cell therapy in participants with CD30-positive relapsed or refractory lymphoma.

Conditions

• Relapsed or Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	CD30 CAR-T Cells	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: 2025-03-04
• Primary completion: 2027-03-31
• Completion: 2029-03-31
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: China