Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) ).
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients. [Time frame: Up to 15 years from enrollment]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 6 centers
- Peking University First Hospital — Beijing
- People's Hospital of Peking Universit — Beijing
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin
- Tianjin Medical University General Hospital — Tianjin
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07028970 · CT103AC003