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This is a prospective long-term follow-up (LTFU) study to evaluate the long-term safety and survival benefit for patients who received at least one of CARsgen's GM T cell product in a clinical trial or as a commercially available product. In this study, patients will be followed for up to 15 years after last GM T-cell infusion for the evaluation of delayed adverse events (AEs), vector persistence, potential risk for integration, and survival time due to GM T-cell exposure.
As recommended by Health Authorities guidelines for human gene therapy products containing an integrated transgene, during the LTFU for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, AEs, survival information, etc. AEs recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. Samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use.
All participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevorcabtagene Autoleucel | Drug | Non-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the risk of delayed AEs following exposure to GM T cells | 15 years |
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Inclusion Criteria:
- 1. All patients who have received at least one GM T-cell infusion in the parent clinical study or in the post-approval setting.
2. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For patients incapable of providing consent, the signed ICF of their legally accepted guardians must be obtained.
Exclusion Criteria:
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Before any study procedure, informed consent must be signed by the participants, or by the participant's legal guardian for patients with no full civil capacity
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yajing Zhang | Contact | 18601333856 | 23975701@qq.com |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |