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NCT Number: NCT07028970

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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

Treatment and study plan

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

Other

This study is observational study and all participants will be obsreved with no intervention.

Primary outcomes

  1. To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.

    Time frame: Up to 15 years from enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanjing IASO Biotechnology Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2040
Study completion
2043
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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