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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients received Equecabtagene Autoleucel Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile of Equecabtagene Autoleucel Injection in treated patients. | Up to 15 years from enrollment |
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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those who participated in pre-marketing clinical studies or post-marketing real-world studies, must have completed or withdrawn from the original study; 3.Voluntary signing of an informed consent form approved by the ethics committee.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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Ye | Contact | +86 025-58287610 | wen.ye@iasobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Li, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Juan Du, PhD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Not yet recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| People's Hospital of Peking Universit | Not yet recruiting | Beijing | China |
|
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | China |
|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | China |
|
| Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | China |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |