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

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT07028970
• Lead Sponsor: Nanjing IASO Biotechnology Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2024-12-15
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2040-12
• Study Completion: 2043-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 1.Received Equecabtagene Autoleucel Injection treatment; 2.For those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.

Exclusion Criteria

• 1. Receipt of another lentiviral vector-based cell or gene therapy (either commercialized product or investigational product in a clinical tiral) between the infution of Equecabtagene Autoleucel Injection and the signing informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.	Up to 15 years from enrollment

Trial Locations

Locations (6)

Peking University First Hospital; 🇨🇳 Beijing, China

People's Hospital of Peking Universit; 🇨🇳 Beijing, China

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China