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The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.
This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products.
No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol.
In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynKIR-110 | Participants who previously received SynKIR-110 in an interventional trial |
| |
| SynKIR-310 | Participants who previously received SynKIR-310 in an interventional trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynKIR-110 | Drug | Autologous T cells Transduced with Mesothelin KIR-CAR |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product | Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product | Up to 15 years from SynKIR CAR T cell product administration |
| To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product | Presence of RCL VSV-G DNA | Up to 15 years from SynKIR CAR T cell product administration |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term clinical efficacy of SynKIR CAR T cell product | Overall survival | Up to 15 years from SynKIR CAR T cell product administration |
| To assess the long-term clinical efficacy of SynKIR CAR T cell product |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
There are no specific exclusion criteria.
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Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product in a Verismo Therapeutics parent protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States | ||
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| SynKIR-310 |
| Drug |
Autologous T Cells transduced with CD19 KIR-CAR |
|
Progression-free survival
| Up to 15 years from SynKIR CAR T cell product administration |
| To assess the persistence of SynKIR-modified T cells | Presence of a SynKIR CAR DNA sequence | Up to 15 years from SynKIR CAR T cell product administration |
| Winship Cancer Institute of Emory University |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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