NCT07002112

The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec100 product in the Treatment of Relapsed/Refractory B-cell Malignancies.

Detailed description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LVIVO-TaVec100 product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of LVIVO-TaVec100 product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

Conditions

• Relapsed/Refractory B-cell Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	LVIVO-TaVec100 product	Prior to infusion of the LVIVO-TaVec100 product, subjects will receive bridging therapy if needed.

Timeline

• Start date: 2025-05-23
• Primary completion: 2027-06-30
• Completion: 2029-06-30
• First posted: 2025-06-03
• Last updated: 2025-08-12

Locations

6 sites across 1 country: China