NCT06791681

A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma

Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed/refractory Multiple Myeloma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chunrui Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.

Detailed description

ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR. Before infusion, the patients will be given the prophylaxis of acetaminophen and diphenhydramine. The designed dose-escalation includes four dose groups of dose A, B, C, and D. After infusion, patients will be followed for 2 years.

Conditions

• Relapsed/ Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ESO-T01	ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR.

Timeline

• Start date: 2025-01-27
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-01-24
• Last updated: 2025-02-11

Locations

1 site across 1 country: China