NCT07028970

Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm, long-term follow-up clinical study. All patients who have received Equecabtagene Autoleucel Injection treatment will be enrolled.

Detailed description

The main follow-up period for pre-marketing clinical studies related to Equecabtagene Autoleucel Injection is 2 years. The "Technical Guidelines for Long-term Follow-up Clinical Studies of Gene Therapy Products (Trial)" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) recommends a follow-up period of not less than 15 years for gene therapy products with genomic integration activity. In order to observe the long-term safety and efficacy of Equecabtagene Autoleucel Injection, as well as the persistence of CAR-T cells in vivo, and to identify whether there are differences in safety among populations with different indications, this study will conduct long-term follow-up in patients treated with Equecabtagene Autoleucel Injection, thereby identifying long-term risks and helping to evaluate the product's benefit-risk profile.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )	This study is observational study and all participants will be obsreved with no intervention.

Timeline

• Start date: 2024-12-15
• Primary completion: 2040-12-01
• Completion: 2043-12-01
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

6 sites across 1 country: China