Thinking of joining a study?

Register your interest

Become a volunteer?

NCT07028970 | RECRUITING | Multiple Myeloma

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

Condition or disease

Multiple Myeloma

Intervention/treatment

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

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 Type : OBSERVATIONAL
Estimated Enrollment : 1500 participants
Official Title : Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection
Actual Study Start Date : 2024-12-15
Estimated Primary Completion Date : 2040-12
Estimated Study Completion Date : 2043-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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.
Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection

Location Details

NCT07028970

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

China,

Peking University First Hospital

Beijing, China,

NOT YET RECRUITING

China,

People's Hospital of Peking Universit

Beijing, China,

RECRUITING

China,

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China,

RECRUITING

China,

Tianjin Medical University General Hospital

Tianjin, China,

NOT YET RECRUITING

China,

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China,

NOT YET RECRUITING

China,

Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University

Zhengzhou, China,