NCT06691685

A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma.

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (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, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of ESO-T01 for patients with relapsed/refractory multiple myeloma.

Detailed description

This investigator-initiated clinical study aims to evaluate ESO-T01, the third-generation self-inactivating lentiviral vector that carries a BCMA-targeted CAR, in patients with relapsed refractory multiple myeloma (MM). The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ESO-T01 Injection	ESO-T01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries an effective BCMA-targeted CAR. ESO-T01 can be administered intravenously and produce CAR-T in vivo.

Timeline

• Start date: 2024-11-18
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2024-11-15
• Last updated: 2025-03-25

Locations

1 site across 1 country: China