Long-term follow-up of Eque-cel (Equecabtagene Autoleucel) for multiple myeloma

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

This follow-up will see how people with multiple myeloma who previously received Eque-cel (Equecabtagene Autoleucel) are doing over time.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Sex: All
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. (industry)
• Drugs / interventions: CAR-T
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT07028970 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-arm registry enrolls people who have already received Equecabtagene Autoleucel (Eque-cel) to track long-term outcomes. Participants will be followed periodically to collect safety data, clinical status, and measurements of CAR-T cell persistence, with no new investigational interventions administered. The initial post-marketing follow-up period is two years for pre-marketing studies, while national technical guidance recommends extended monitoring (up to 15 years) to detect late effects related to genomic integration. Data will be used to identify long-term risks and differences in safety across populations to inform the product's benefit–risk profile.

Who should consider this trial

Good fit: Ideal candidates are people with multiple myeloma who have already received Eque-cel in a prior clinical or real-world setting and who can provide informed consent.

Not a fit: Patients who have not received Eque-cel or who received another lentiviral-vector cell or gene therapy after their Eque-cel infusion (and before signing consent) are unlikely to benefit from this registry.

Why it matters

Potential benefit: If successful, the registry could reveal late side effects and how long Eque-cel benefits last, helping doctors manage long-term care and improve patient safety.

How similar studies have performed: Other CAR-T products for multiple myeloma have published long-term follow-up showing durable responses and safety monitoring, but long-term data specific to Eque-cel remain limited.

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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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

Where this trial is running

Beijing and 5 other locations

• 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)

Study contacts

• Principal investigator: Jian Li, PhD — Peking Union Medical College Hospital
• Study coordinator: Wen Ye

Conditions: Multiple Myeloma, Long term follow up, Eque-cel