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

IASO Biotherapeutics

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Other: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )

Study type: Observational

Funder types: Industry

Identifiers

NCT07028970

CT103AC003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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

Trial design

1,500 participants in 1 patient group

All patients received Equecabtagene Autoleucel Injection

Treatment:

Other: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )