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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07028970

Enrollment

1500

Registered

2025-06-19

Start date

2024-12-15

Completion date

2043-12-31

Last updated

2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Long term follow up;, Eque-cel

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.

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

OTHERNo Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.	Up to 15 years from enrollment

Countries

China

Contacts

Primary ContactWen Ye

wen.ye@iasobio.com+86 025-58287610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026