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

NCT07028970 | Recruiting DMC

• 1 other identifier: CT103AC003
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 6

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.

Conditions

Multiple Myeloma

Keywords

Long term follow up;; Eque-cel

Outcome Measures

Primary Outcomes (1)

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

  Up to 15 years from enrollment

Study Arms (1)

All patients received Equecabtagene Autoleucel Injection

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

Interventions

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.

All patients received Equecabtagene Autoleucel Injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who have received Equecabtagene Autoleucel Injection treatment. Patients who participated in pre-marketing clinical studies or post-marketing real-world studies with this product can only be enrolled after completing or prematurely withdrawing from their original studies.

You may qualify if:

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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Nanjing IASO Biotechnology Co., Ltd.: lead

Study Sites (6)

Peking University First Hospital

Beijing, China

NOT YET RECRUITING

People's Hospital of Peking Universit

Beijing, China

NOT YET RECRUITING

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

Tianjin, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

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

Wuhan, China

NOT YET RECRUITING

Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jian Li, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Juan Du, PhD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Ye

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2043
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)