NCT07240974

Safety and Efficacy of ZZSW-01 in Relapsed/Refractory B-cell Malignancies

A Clinical Study to Evaluate the Safety and Efficacy of ZZSW-01 in the Treatment of Patients With Relapsed/Refractory B-cell Malignancies

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed/refractory B-cell malignancies.

Detailed description

This investigator-initiated clinical study aims to evaluate ZZSW-01 injection, the extracellular vesicle vector that carries CD19 CAR mRNA, in patients with relapsed/refractory B-cell hematologic malignancies. Under this design, eligible subjects will receive multiple injections. The study adopts a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Conditions

• Relapsed/Refractory B-cell Malignancies

Interventions

Type	Name	Description
DRUG	ZZSW-01 injection	ZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.

Timeline

• Start date: 2025-10-28
• Primary completion: 2028-09-15
• Completion: 2028-09-15
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: China