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This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.
Patients treated with Inaticabtagene Autoleucel Injection (including registered clinical trial patients with different indications of this product and commercialized patients after market launch), would be included in this program for a maximum of 15 years of long-term follow-up (LTFU), and an informed consent form must be signed again. The research period was 15 years after Inaticabtagene Autoleucel infusion. The patient was followed up once a year for 15 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inaticabtagene autoleucel Injection | Other | Inaticabtagene autoleucel Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Replication-competent lentivirus，RCL | Real time quantitative polymerase chain reaction was used for detection, QPCR method. | once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Adverse Drug Reaction | Individual adverse drug reactions related to Inaticabtagene Autoleucel Injection after marketing, mainly including secondary tumors, etc after marketing, mainly including secondary tumors, etc | once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years. |
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Inclusion Criteria:
Exclusion Criteria:
- None.
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Registered clinical trial patients with different indications and post market commercialized patients who have received treatment with Inaticabtagene Autoleucel Injection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinling Wu | Contact | +86 13161292425 | wuyinling@juventas.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr. | Institute of Hematology & Blood Diseases Hospital, Tianjin, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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