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

NCT ID: NCT07028970

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-15

Study Completion Date

2043-12-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients received Equecabtagene Autoleucel Injection

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

Intervention Type OTHER

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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing IASO Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Juan Du, PhD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Peking University First Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

People's Hospital of Peking Universit

Beijing, , China

Site Status NOT_YET_RECRUITING

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

Tianjin, , China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, , China

Site Status RECRUITING

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

Wuhan, , China

Site Status NOT_YET_RECRUITING

Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University

Zhengzhou, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Wen Ye

Role: CONTACT

+86 025-58287610

Facility Contacts

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Yujun Dong

Role: primary

+86 18210264969

Jin Lu

Role: primary

+86 13311491805

Dehui Zou

Role: primary

+86 13602100955

Rong Fu

Role: primary

+86 13920350233

Chunrui Li

Role: primary

+86 13647233185

Baijun Fang

Role: primary

+86 13526607830

Other Identifiers

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CT103AC003

Identifier Type: -

Identifier Source: org_study_id

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