Multiple MyelomaNCT07028970
Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection
An observational study of Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 6 sitesChina
- Study dates
- 15 Dec 2024to Dec 2043
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing
Yujun Dong, +86 18210264969, dongy@hsc.pku.edu.cn
- Not yet recruiting
People's Hospital of Peking Universit
Beijing
Jin Lu, +86 13311491805, jin1lu@sina.com
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Dehui Zou, +86 13602100955, zoudehui@ihcams.ac.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Rong Fu, +86 13920350233, furong8369@tmu.edu.cn
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Chunrui Li, +86 13647233185, cunrui5650@126.com
- Not yet recruiting
Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University
Zhengzhou
Baijun Fang, +86 13526607830, fdation@126.com
About this study
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )
- Keywords
- Long term follow up;, Eque-cel
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients received Equecabtagene Autoleucel Injection | Not described Receives: Other: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.
Measured: Up to 15 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Dec 2024
- Primary completionDec 2040 (estimated)
- Study completionDec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Nanjing IASO Biotechnology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Li, PhD, Principal investigator, Peking Union Medical College HospitalJuan Du, PhD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028970
- Sponsor's protocol ID
- CT103AC003
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Registry Study of Equecabtagene Autoleucel Injection
- ClinicalTrials.gov ID
- NCT07028970
- Acronym / sponsor ID
- CT103AC003
- Conditions
- Multiple Myeloma
- Keywords
- Long term follow up;, Eque-cel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2043 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients received Equecabtagene Autoleucel Injection | – | Other: No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention (subjects were previously treated with Equecabtagene Autoleucel Injection) )This study is observational study and all participants will be obsreved with no intervention. | Other | All patients received Equecabtagene Autoleucel Injection |
Primary outcome
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients.
Time frame: Up to 15 years from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Li, PhD principal investigator
Peking Union Medical College Hospital
Juan Du, PhD principal investigator
RenJi Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Ye (+86 025-58287610, wen.ye@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients. (time frame: Up to 15 years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.